Jobs in the United States

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Added 1 min ago
Reliability Engineer
Louisville, CO · Salt Lake City, UT · Houston, TX
The Reliability Engineer supports a larger operations team and serves as a domain expert for technical and engineering matters related to the reliable and available operation of MV/HV…
Added 2 mins ago
CI
Senior Systems Engineer
Cintal, Inc.
Chillicothe, IL
- $80,000 to $105,000 USD / year
Implement system enhancements to improve reliability, performance, and scalability
Added 2 mins ago
AR
Systems Engineer - Journeyman
Applied Research Solutions
Bedford, MA
- $140,000 to $154,000 USD / year
Applied Research Solutions is seeking a full-time Systems Engineer at Hanscom AFB, in Bedford, Massachusetts.
Added 5 mins ago
Senior Software Development Engineer, EC2 Trainium AI Infra
Amazon.com Services LLC
Seattle, WA
The Software Development Engineer will lead the team in technical strategy, design, build, and operation of infrastructure services including provisioning and availability of AWS…
Added 5 mins ago
Software Development Engineer
Amazon.com Services LLC
Seattle, WA
…work will directly impact latency, data quality, and platform…
Added 5 mins ago
Senior Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Software Development Engineer II, AWS IAM AuthRuntimeClient
Amazon Development Center U.S., Inc.
Arlington, VA
The AuthRuntimeClient (ARC) team at Amazon Web Services (AWS) is looking for a Software Development Engineer to build, deliver, and maintain complex products that delight our customers and…
Added 5 mins ago
Systems Development Engineer II, US Amazon Dedicated Cloud Security Engineering
Amazon.com Services LLC
Herndon, VA
AWS Security is looking for a driven Systems Development Engineer to build and maintain the automation that enables security assurance at scale. You will work among a larger team to…
Added 5 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Sr. Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Software Dev Engineer, Amazon Leo Customer Terminal Software
Amazon Kuiper Manufacturing Enterprises LLC
Austin, TX · Redmond, WA
…Linux system. We work hand in hand with hardware, product and operations teams to deliver a great experience for our…
Added 5 mins ago
Manufacturing Engineer II
Wilson Tool International
White Bear Lake, MN
As a Manufacturing Engineer II at Wilson Tool, you will focus on optimizing processes to support safe, efficient, and high-quality production. This role plays a key part in advancing…
Added 8 mins ago
BG
System Integration Engineer, Baggage Handling System
BEUMER Group
Hebron, KY
- $100,000 to $120,000 USD / year
The System Integration Engineer is responsible for the integration of mechanical, electrical, low-level controls, and high-level software and continuous improvement of the BEUMER Individual…
Added 9 mins ago
IG
REMOTE ML Ops Engineer
Insight Global
Remote, United States
- From $71 USD / hour
…business areas, including clinical, insurance, and financial operations. They have several machine learning models already deployed within their environment and are seeking an experienced…
Added 9 mins ago
RE
Customer Data Traceability Engineer
Renesas Electronics
Palm Bay, FL
- $159,000 to $198,000 USD / year
…strategic customer-engagement levels. The Senior Staff Quality Engineer will partner with customer engineering, supplier quality, operations, and executive teams while coordinating Renesas…
Added 12 mins ago
CO
Core Research Software Engineer I - Integrated Genomics Core
Career Opportunities
La Jolla, CA
- $33 to $38 USD / hour
The Salk Institute Core Facilities are looking for a Research Software Engineer to assist in daily systems administration and operational support for the technology infrastructure that…
Added 13 mins ago
U
Staff Software Engineer - Michelangelo Job Controller Team
Uber
Sunnyvale, CA · San Francisco, CA
- $232,000 to $258,000 USD / year
Leading at Uber means setting direction in motion, not waiting for perfect conditions. As a Senior Software Engineer on the Michelangelo Job Controller team, you will help build the compute…
Added 13 mins ago
G
Maintenance Engineer
GPAC
Eden Prairie, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.

Nova Biomedical

Sr. QC Manager

Waltham, MA, United States

$150,000 to $170,000 USD / year

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Job details

Pay: $150,000 to $170,000 USD / year
Experience: 5–10+ years of Quality Control management experience within an FDA-regulated medical device, IVD, or reagent manufacturing environment.
Posting language: English
Posted: Jul 21, 2026

Original job description

Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Job Summary:

The Sr. Quality Control Manager is responsible for leading and scaling Quality Control (QC) operations across multiple U.S. manufacturing facilities in Waltham, Norwood, and Billerica, Massachusetts, supporting the production of biotechnology and clinical systems, including point-of-care (POC) and in vitro diagnostic (IVD) medical devices, consumables, and reagents.

This role ensures product quality, regulatory compliance, and operational excellence throughout the manufacturing lifecycle, with a strong emphasis on data-driven quality management, statistical monitoring, and continuous improvement. The Sr. Quality Control Manager will develop and execute comprehensive quality control strategies that support FDA medical device requirements, MDSAP, IVDR, ISO 13485, ISO 14971, and other applicable regulatory standards while enabling scalable growth across the organization.

The ideal candidate will be a collaborative leader who partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and Operations leadership to drive quality objectives, business expansion, and commercialization goals.

Responsibilities:

Lead Quality Control functions across multiple manufacturing and distribution sites within the United States.
Establish and maintain enterprise-wide QC strategies, policies, procedures, and performance metrics.
Build, develop, and mentor high-performing Quality Control teams while fostering a culture of accountability, compliance, and continuous improvement.
Ensure consistency of QC practices, testing methodologies, and inspection standards across all facilities.
Drive operational excellence initiatives that improve product quality, efficiency, and scalability.
Establish robust systems for collecting, monitoring, analyzing, and reporting product quality and manufacturing performance data.
Proactively identify trends, emerging product risks, recurring defects, process shifts, and performance gaps to support continuous improvement.
Lead root cause investigations using structured problem-solving methodologies and statistical tools.
Analyze quality, yield, reliability, complaint, nonconformance, and production output data to improve product performance and manufacturing capability.
Ensure compliance with FDA, MDSAP, IVDR, ISO, and other applicable regulatory requirements and harmonized standards.
Oversee the management of documentation, records, test reports, deviations, investigations, CAPAs, and quality metrics.
Collaborate with R&D, Supplier Quality, Incoming Inspection, Manufacturing, Manufacturing Engineering, Finished Goods, and Distribution teams to drive quality improvements.
Support engineering and manufacturing quality initiatives through the effective use of procedures, processes, quality engineering tools, and data analysis.

Experience Requirements:

Bachelor's degree or higher in a technical discipline, preferably within Life Sciences, Chemistry, Medical Technology, or a related field.
5–10+ years of Quality Control management experience within an FDA-regulated medical device, IVD, or reagent manufacturing environment.
Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820.
Experience developing product and process trend analyses, nonconformance reduction programs, risk reduction initiatives, cost containment efforts, and executive-level quality reporting.
Experience applying product lifecycle risk management principles for IVD medical devices.
Experience linking QC trends, nonconformances, complaint investigations, and manufacturing performance data to product risk management activities.
Experience with process and equipment validation activities, including authoring and reviewing IQ, OQ, and PQ documentation.
Experience authoring Quality Plans and Quality Control Plans.
Experience supporting multi-site manufacturing operations.
Strong project management, leadership, and team development skills.
ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Green Belt Six Sigma certification preferred.

Physical Requirements and Working Conditions:

Comfort with working at a computer for extended periods.
Capacity to lift and carry up to [25–50] pounds as required
Able to communicate effectively via phone, video, and written communication.
Occasional need to move about the office to access meetings or resources.

Why Work for Nova Biomedical

Flexible Medical, Dental, & Vision Coverage
Competitive 401k company match
Bonus Program, Generous PTO and paid holidays
Generous Tuition reimbursement
Hybrid and flexible work arrangements
Professional development, engagement and events
Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
Company subsidized cafeteria in our Waltham, MA office

Work Location: Waltham, MA

Targeted Salary Range: $150,000-$170,000/yr

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

About the Company

At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

Explore what’s next with us at novabiomedical.com

EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

https://www.novabiomedical.com/privacy-policy/

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More about this job

Skills

Quality control
Biotechnology
Medical devices
Regulatory compliance
Quality assurance procedures
Process improvement
Quality assurance
Regulatory affairs
Leadership
Inspection
Reporting
Problem solving
Documentation
Data analysis
Risk management
SAP IQ
Project management
Team building
Lean Six Sigma Green Belt
Lean manufacturing
Communication skills

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