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Added 14 mins ago
IT Program Manager
Jobgether
Remote, United States
12+ years of IT program or project management experience, including at least 5 years managing large federal IT services contracts valued at $10 million or more annually as a Program Manager.
Added 27 mins ago
Project Manager - Providence Alaska Medical Center
Providence
Anchorage, AK
We are hiring for Project Manager position at Providence Alaska Medical Center in Anchorage, AK!
Added 27 mins ago
EG
Business Systems Analyst (BSA)
Eliassen Group
Juneau, AK
- $70 to $80 USD / hour
…communications, and organizational execution. This is not a traditional technical BSA or Project Manager role. The ideal candidate operates as a strategic generalist, helping create…
Added 30 mins ago
NS
GENERAL BUSINESS AND INDUSTRIAL SPECIALIST
Naval Sea Systems Command
Bath, ME
- $120,548 to $156,715 USD / year
You will serve as a Test Manager with the responsibility of independently planning, integrating, coordinating, analyzing, and managing one or more complex projects, products, initiatives,…
Added 33 mins ago
OB
Personnel Liaison Specialist
Offices, Boards and Divisions
Washington, DC
- $102,415 to $158,322 USD / year
With minimal direction provides program planning and project management support on HR issues.
Added 33 mins ago
FA
Aviation Safety Inspector
Federal Aviation Administration
Greensboro, NC
- $125,776 to $163,514 USD / year
The ASI keeps management informed of the status of all programs and projects and is held accountable for the technical accuracy, proper coordination, and timeliness of completed staff work.…
Added 33 mins ago
FA
Program Manager (Business Analysis & Formulation)
Federal Aviation Administration
Washington, DC
- $150,392 to $228,000 USD / year
…align with the objectives of AJV, the ATO, and the FAA. The Program Manager must apply a deep understanding of the technical aspects of budget formulation and business analysis to guide the…
Added 33 mins ago
AN
SUPERVISORY LOGISTICS MANAGEMENT SPECIALIST
Army National Guard Units
Carson City, NV
- $99,218 to $128,987 USD / year
…programs. Ensures compliance with excess supply and equipment program. Manages stock record account(s). Ensures compliance with the Internal Control Program for installation supply and…
Added 36 mins ago
VH
Lead Health System Specialist (Credentialing and Privileging)
Veterans Health Administration
West Haven, CT
- $88,005 to $114,413 USD / year
…responsible for providing lead administrative, consulting, technical direction and support to the C&P Specialists, C&P Manager and to program…
Added 36 mins ago
US
TEST ADMINISTRATOR
United States Space Force
El Segundo, CA
- $34,799 to $82,938 USD / year
The primary purpose of this position is: To function as the installation's testing program manager/Test Control Officer (TCO). Responsible for the management and administration of the Air…
Added 36 mins ago
FA
Civil Engineer
Federal Aviation Administration
FAA Nationwide-Selectee Remains in Current Duty Location
- $95,489 to $148,037 USD / year
This position serves as a regional office senior Civil Engineer and lead project engineer for the Office of Airports (ARP), New York Airports District Office in the Eastern Region, in…
Added 36 mins ago
NR
Reactor Engineer (Examiner Qualified)
Nuclear Regulatory Commission
Rockville, MD
- $143,913 to $187,093 USD / year
Candidates must have a strong technical and project management background with excellent written and oral communications skills.
Added 36 mins ago
FA
Program Manager
Federal Aviation Administration
El Segundo, CA
- $130,314 to $202,026 USD / year
The Operations Support Manager (OSM) position serves as first level Manager of an assigned workforce consisting of Management & Program Analysts and/or assistants, Administrative Officers,…
Added 36 mins ago
GA
Website Manager | Salary - Corporate Accounting Office
Gee Automotive Companies
Milwaukie, OR
- $65,000 to $75,000 USD / year
We're looking for an organized, detail-oriented Website Manager to oversee and optimize websites across our dealership group. This role plays a critical part in ensuring our websites remain…
Added 37 mins ago
F/A-18 & EA-18G Senior Project Manager
The Boeing Company
Berkeley, MO
Program management best practices, project management skills, strong communication skills, and constructive engagement with all stakeholders (internal partners, suppliers, and customers)…
Added 41 mins ago
G
Water/Wastewater Engineer
GPAC
Raleigh, NC
- $90,000 to $150,000 USD / year
Clear Growth Path: From Engineer → Project Manager → Technical Lead → Partner – we map it out with you.
Added 45 mins ago
J
Senior GIS Project Manager
Jobgether
Remote, United States
- $93,000 to $115,000 USD / year
The Senior GIS Project Manager will oversee the planning, coordination, and delivery of complex technology and data-focused projects, with an emphasis on GIS and related technical…
Added 46 mins ago
VH
Management and Program Analyst
Veterans Health Administration
Location Negotiable After Selection
- $89,508 to $138,370 USD / year
Develops and maintains project plans for analysis, design, testing, implementation, and maintenance of decision support, program evaluation, and strategic tracking initiatives.
Added 46 mins ago
VB
Management and Program Analyst
Veterans Benefits Administration
Salt Lake City, UT · Washington, DC · Indianapolis, IN · Philadelphia, PA · Saint Paul, MN
- $63,795 to $118,204 USD / year
Serves as project manager for major initiatives and special assignments. Monitors and tracks progress on internal and external audit findings and investigates operational issues such as…
Added 46 mins ago
VH
Supervisory Healthcare Engineer (Detail/Temporary Promotion NTE 120 Days)
Veterans Health Administration
Tuskegee, AL
- $140,025 to $182,034 USD / year
Prepares correspondence, technical reports, estimates, fact sheets, status reports, and schedules as required to complete project assignments
Added 48 mins ago
VH
Social Worker Program Coordinator - Psychosocial Rehabilitation and Recovery Services
Veterans Health Administration
Seattle, WA
- $119,630 to $155,521 USD / year
This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in…
Added 48 mins ago
VH
Social Worker Program Coordinator - Psychosocial Rehabilitation and Recovery Services
Veterans Health Administration
Seattle, WA
- $119,630 to $155,521 USD / year
This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in…
Added 51 mins ago
CF
IT Program Manager (DataMgt)
Centers for Medicare & Medicaid Services
Farmington Hills, MI
- $117,402 to $152,625 USD / year
As an IT Program Manager (DataMgt), GS-2210-13, you will provide technical expertise in advanced data systems analysis and design to drive solutions for CMS health programs.
Added 51 mins ago
VH
Acquisition & Utilization Specialist
Veterans Health Administration
McClellan, CA
- $68,419 to $107,620 USD / year
…services, product acquisition and support services required by project managers, program managers, upper management, and stakeholders on all aspects of procurement for a wide variety of…
Added 51 mins ago
AM
GENERAL ENGINEER
Air Mobility Command
Scott AFB, IL
- $128,967 to $167,663 USD / year
The primary purpose of this position is to serve as the AMC Program Manager reporting directly to the Air Mobility Command Chief of Staff (General Officer) for renovation of facilities and…

Aptyx

Quality Assurance Manager

Charlotte, NC, United States

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Job details

Posting language: English
Posted: Nov 4, 2026

Original job description

POSITION SUMMARY

The Quality Assurance Manager is responsible for leading the site's Quality Assurance and Regulatory Compliance functions, ensuring Aptyx Charlotte maintains compliance with applicable U.S. FDA requirements, international medical device regulations, and relevant industry standards. This role provides strategic direction and operational oversight of the Quality Management System (QMS), regulatory compliance, product quality, supplier quality, and audit readiness to ensure safe, effective, and compliant products are delivered to customers.

Working in a contract product development and manufacturing environment, this position partners closely with Research & Development (R&D), Engineering, Program Management, Operations, and other cross-functional teams to support medical device development from concept through commercialization and production. Products include disposable medical devices such as catheters, catheter-based delivery systems, and other devices supporting clinical disciplines including cardiology, neurology, and urology.

The Quality Assurance Manager serves as the site's Management Representative, providing leadership and oversight of quality systems, regulatory activities, customer and supplier quality requirements, and continuous improvement initiatives. This position leads the Quality team, develops departmental capabilities, and drives a culture of quality, accountability, and continuous improvement throughout the organization.

DUTIES AND RESPONSIBILITIES

Quality Leadership & Regulatory Compliance

Develop and execute the site's quality and regulatory strategies in alignment with business objectives, customer requirements, and applicable regulatory standards.
Maintain, implement, and continuously improve the Quality Management System to ensure compliance with applicable FDA regulations, ISO 13485, ISO 14971, and international medical device requirements.
Serve as the site's Management Representative, fulfilling applicable responsibilities outlined in the Management Responsibility Procedure (003816).
Maintain FDA site establishment registration and support ongoing ISO 13485 certification.
Serve as the primary site liaison with regulatory agencies, including the FDA, and coordinate timely responses to regulatory inquiries and customer requests.
Ensure appropriate systems, procedures, and controls are established for product acceptance, final inspection, and lot release.
Oversee process, equipment, and facility qualification and validation programs.
Ensure appropriate controls are maintained for calibration, metrology, environmental monitoring, and other applicable quality systems.
Oversee supplier and supply chain quality, including raw materials, external service providers, and sterilization processes.
Ensure compliance with applicable Customer Quality Agreements and Supplier Quality Agreements.

Audit Management & Continuous Improvement

Lead and support external regulatory, customer, and certification audits, including preparation, execution, responses, and corrective action follow-up.
Serve as Lead Auditor for the internal audit program, ensuring audits are conducted effectively and in accordance with regulatory and QMS requirements.
Champion the annual Management Review process, ensuring required inputs, outputs, and follow-up actions are completed.
Direct and oversee the Material Review Board (MRB), customer complaint, nonconformance, and Corrective and Preventive Action (CAPA) systems.
Apply structured problem-solving and root cause analysis methodologies to identify, investigate, communicate, and resolve quality issues.
Identify opportunities to improve quality systems, processes, and operational performance.

R&D and New Product Development Support

Provide quality and regulatory leadership throughout product development, from concept through design transfer and production.
Partner with R&D and Engineering leaders to establish and implement appropriate design controls based on risk management, customer requirements, and manufacturability.
Ensure design inputs, outputs, reviews, verification, and validation activities are appropriately documented and compliant with QMS requirements.
Develop, maintain, and review Design History Files (DHF) on behalf of customers.
Lead and contribute to risk management activities in accordance with ISO 14971.
Review technical documentation, protocols, test reports, and quality records to ensure compliance with applicable requirements.
Support the development and optimization of inspection procedures, sampling plans, and quality control methods based on critical design attributes, risk, and statistical rationale.
Ensure appropriate measurement and metrology methods are established and utilized.
Monitor customer regulatory submissions, compliance inquiries, and audit findings, communicating relevant lessons learned and supporting responses to product and quality system-related questions.

Department & People Leadership

Lead, develop, and manage the Quality department, ensuring appropriate staffing, resource allocation, workload management, and employee development.
Partner with R&D and other functional leaders to ensure quality resources are appropriately deployed across development projects and operational priorities.
Establish departmental objectives, performance expectations, and Key Performance Indicators (KPIs).
Provide ongoing coaching, mentoring, and feedback to direct reports through regular performance discussions and formal performance reviews.
Support employee engagement, accountability, and professional development within the Quality organization.
Manage the recruitment, selection, and onboarding of Quality personnel in accordance with company policies.
Address employee performance and disciplinary matters in partnership with Human Resources.
Provide guidance and training to employees throughout the organization regarding internal quality procedures, regulatory standards, and customer requirements.

Customer & Cross-Functional Partnership

Partner with customers and internal stakeholders to address quality concerns, escalations, and regulatory requirements while maintaining strong customer relationships.
Ensure customer quality commitments and contractual quality requirements are understood and fulfilled.
Collaborate with Operations, Engineering, R&D, Program Management, and Supply Chain to ensure quality is integrated into business and project decisions.
Provide quality resources, technical guidance, and regulatory expertise to support organizational objectives.
Communicate departmental performance, significant quality issues, risks, and improvement initiatives to site leadership.

QUALIFICATIONS

Demonstrated leadership experience with the ability to lead teams, manage competing priorities, and drive results in a dynamic environment.
Proven ability to establish and promote a culture of quality, accountability, employee engagement, and continuous improvement.
Mandatory medical device quality experience, including involvement in complex product development and manufacturing projects.
Certified ISO 13485 Lead Auditor or equivalent recognized auditor certification.
Six Sigma Black Belt certification preferred.
Demonstrated ability to influence and collaborate with cross-functional teams and senior leadership.

EDUCATION

Bachelor's degree in Engineering or a related technical discipline, or equivalent combination of education and relevant experience.

EXPERIENCE

Minimum of five years of Quality Engineering or Quality Assurance experience within the medical device industry.
Experience supporting new product development and design control activities preferred.
Experience with ISO quality management systems and FDA-regulated environments.
Demonstrated experience leading quality assessments, internal audits, external audits, and regulatory inspections.
Experience developing, implementing, and maintaining Quality Management Systems.
Experience with Design History Files, risk management, verification, and validation activities.
Previous experience supervising, developing, and managing employees preferred.
Experience in a contract product development and manufacturing environment preferred.

SKILLS, KNOWLEDGE & ABILITIES

Strong working knowledge of ISO 13485, ISO 14971, and applicable FDA medical device regulations, including 21 CFR Part 820.
Knowledge of international medical device regulatory requirements and quality standards.
Technical understanding of disposable medical device testing, protocols, data analysis, and technical report writing.
Knowledge of statistical methods, including Statistical Process Control (SPC), Design of Experiments (DOE), and sampling methodologies.
Strong analytical, investigative, and problem-solving capabilities.
Demonstrated ability to lead teams, influence stakeholders, and effectively manage resources.
Excellent written, verbal, presentation, and interpersonal communication skills.
Strong organizational skills with the ability to prioritize, manage multiple initiatives, and meet business objectives.
Proficiency in Microsoft Office and applicable quality management systems.
Ability to work independently while fostering collaboration and teamwork.

REGULATORY & QUALITY REQUIREMENTS

Ensure ongoing compliance with applicable U.S. FDA and international medical device regulations and industry standards.
Maintain the site's ISO 13485 certification and associated Quality Management System.
Maintain FDA site establishment registration.
Ensure implementation and compliance with ISO 14971 risk management requirements.
Maintain audit readiness and ensure timely resolution of identified quality and regulatory findings.
Ensure appropriate quality controls are maintained throughout product development, manufacturing, and product release.

Acknowledgement

I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.

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Date

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More about this job

Skills

Quality assurance
Regulatory compliance
Medical device regulations
Quality assurance procedures
Research
Program management
Medical devices
Leadership
Quality control systems
Process improvement
Inspection
Supply chain management
Auditing
Problem solving
Root cause analysis
Risk management
Documentation
Quality control
Coaching
Lead a team
Lean Six Sigma Black Belt
Internal auditing
Data analysis
Write technical reports
Statistical process control
SPC
Manage resources
Communication skills
Organizational skills
Microsoft Office
Work independently
Collaboration
Teamwork

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