Jobs in the United States

25+ jobs

Group jobs by employerEmail me new jobs Save this search

Added 7 mins ago
Drone Battery Pack Design Engineer II, Prime Air
Amazon.com Services LLC
Seattle, WA
We are seeking a Drone Battery Pack Design Engineer II to join our Electric Propulsion Subsystem (EPS) team. In this role, you will be a significant and autonomous contributor, solving…
Added 16 mins ago
Electrical Engineer - Flint Area
The Pivot Group Network
Flint · Flint, MI
Instrumentation and Controls Engineer, Electrical Project Engineer, Process Controls Engineer, Facilities Electrical Engineer, Controls Engineer, Automation Engineer, Electrical Design…
Added 17 mins ago
Electrical Applications Engineer – Motor Controls & Drives
Jobgether
Remote, United States
The Electrical Applications Engineer will develop technical proposals and customized motor control and drive solutions for key accounts and strategic partners. This role combines electrical…
Added 17 mins ago
SR
Electrical Designer / Project Manager
STRM Recruiting
Portland, OR
- $90,000 to $170,000 USD / year
Approximately 5–10+ years of relevant electrical design, engineering, or project management experience.
Added 19 mins ago
Electrical Engineer - Sault Ste. Marie Area
The Pivot Group Network
Sault Ste. Marie · Sault Ste. Marie, MI
Maintenance Engineer, Instrumentation and Controls Engineer, Electrical Project Engineer, Process Controls Engineer, Facilities Electrical Engineer, Controls Engineer, Automation Engineer,…
Added 19 mins ago
Electrical Engineer - Dearborn Area
The Pivot Group Network
Dearborn · Dearborn, MI
Maintenance Engineer, Instrumentation and Controls Engineer, Electrical Project Engineer, Process Controls Engineer, Facilities Electrical Engineer, Controls Engineer, Automation Engineer,…
Added 20 mins ago
Quality Engineer II (5856)
Honeywell
Kansas City, MO
You Must Have
Added 20 mins ago
Electrical Engineer II (5925)
Honeywell
Kansas City, MO
You Must Have
Added 22 mins ago
Reliability Engineer - Ironwood Area
The Pivot Group Network
Ironwood · Ironwood, MI
Background in continuous improvement or project management.
Added 22 mins ago
Quality Engineer
Promega
Madison, WI
YOUR ROLE: As a Quality Engineer, you'll lead quality system improvement projects for Promega's medical device business, work governed by ISO 13485 and FDA's Quality Management System…
Added 24 mins ago
RU
Automation Engineer I
Resilience US, LLC
West Chester, OH
- $60,000 to $90,000 USD / year
The Automation Engineer I role is a professional engineer who provides technical and project management support to colleagues in an area of expertise within the engineering function.
Added 25 mins ago
NPI Engineer - Mount Clemens Area
The Pivot Group Network
Mount Clemens · Mount Clemens, MI
Launch Engineer, Manufacturing Project Engineer, Design for Manufacturing Engineer, New Product Introduction Engineer, Manufacturing Engineer, Process Engineer, Production Engineer, Product…
Added 25 mins ago
Electrical Engineer - Saginaw Area
The Pivot Group Network
Saginaw · Saginaw, MI
Manufacturing Engineer, Maintenance Engineer, Instrumentation and Controls Engineer, Electrical Project Engineer, Process Controls Engineer, Facilities Electrical Engineer, Controls…
Added 25 mins ago
Electrical Engineer - Ironwood Area
The Pivot Group Network
Ironwood · Ironwood, MI
Electrical Project Engineer, Process Controls Engineer, Facilities Electrical Engineer, Controls Engineer, Automation Engineer, Electrical Design Engineer, Manufacturing Engineer,…
Added 25 mins ago
Electrical Engineer - Coldwater Area
The Pivot Group Network
Coldwater · Coldwater, MI
Electrical Project Engineer, Process Controls Engineer, Facilities Electrical Engineer, Controls Engineer, Automation Engineer, Electrical Design Engineer, Manufacturing Engineer,…
Added 28 mins ago
Tooling Engineer - Shelby Township Area
The Pivot Group Network
Shelby Township · Shelby Township, MI
Project management experience for tool builds.
Added 28 mins ago
Tooling Engineer - Mount Clemens Area
The Pivot Group Network
Mount Clemens · Mount Clemens, MI
Project management experience for tool builds.
Added 28 mins ago
Reliability Engineer - Iron Mountain Area
The Pivot Group Network
Iron Mountain · Iron Mountain, MI
Background in continuous improvement or project management.
Added 31 mins ago
NPI Engineer - Caro Area
The Pivot Group Network
Caro · Caro, MI
NPI Project Engineer, Launch Engineer, Manufacturing Project Engineer, Design for Manufacturing Engineer, New Product Introduction Engineer, Manufacturing Engineer, Process Engineer,…
Added 32 mins ago
HSE ESTO Diffuser/Combustor Project Lead (P2)
RTX
United States
Qualification You Must Have
Added 35 mins ago
Tooling Engineer - Ironwood Area
The Pivot Group Network
Ironwood · Ironwood, MI
Project management experience for tool builds.
Added 36 mins ago
Electrical Engineer
Hays
NY
As an Electrical Engineer, you’ll work on the design and delivery of mission critical, data center and complex industrial projects.
Added 42 mins ago
Senior Engineer - Body Shop
Volvo Car Corporation
Ridgeville, SC
As a Senior Shop Engineer in our Body Shop, you will provide technical leadership for current and future manufacturing processes across the Body Shop. You will be part of a growing team of…
Added 47 mins ago
Senior Data Center Engineer - AI / HCP Infrastructure
Jobgether
Remote, United States
The Senior Data Center Engineer will lead critical infrastructure projects supporting the rapidly expanding AI and high-performance computing (HPC) industry. This role oversees the full…
Added 57 mins ago
Applied AI Engineer - Engineering Simulation & Design Exploration
Bentley Systems, Incorporated
Philadelphia, PA
…by professionals, and organizations of every size, for the design, construction, and operations of roads and bridges, rail and transit, water and wastewater, public works and utilities,…

Promega

Quality Engineer

Madison, WI, United States

Apply on careers.promega.com About employer

Applications open in a new tab.

Job details

Apply by: Nov 12, 2027
Posting language: English
Posted: Nov 12, 2026

Original job description

OUR TEAM: The Product Quality and Compliance (PQ&C) team at Promega brings together Product Quality Assurance, Quality Systems, and Compliance in one collaborative organization. We make sure Promega's Research Use Only, IVD medical device, and Active Pharmaceutical Ingredient (API) products meet high quality standards for our customers, and that they comply with regulations across a global portfolio. We cover everything from product release and complaint investigation to quality system processes, audits, and regulatory inspections. We work closely with Manufacturing, R&D, Operations, and Supply Chain to find and fix the root causes of quality issues. We value curiosity, accountability, and practical judgment. We're also adopting AI-supported tools so we spend less time on administrative work and more on improving quality.

YOUR ROLE: As a Quality Engineer, you'll lead quality system improvement projects for Promega's medical device business, work governed by ISO 13485 and FDA's Quality Management System Regulation (QMSR). You'll also be a compliance resource as Promega builds its capabilities in Active Pharmaceutical Ingredient (API) manufacturing. You'll scope and drive projects from charter through implementation and improve key processes. You'll support API nonconformance review and GMP compliance, and investigate escalated complaints. Your work will move between RUO, device and API, often in the same week, and you'll help stakeholders see risks to timeline and quality before they become problems. The role has real room to shape how our quality systems grow alongside Promega's expanding organizational capabilities.

JOB OBJECTIVE: Utilize design, engineering and quality principles and practices to support the design and manufacture of products and implement and improve key business and quality processes. Actively support Promega's growing Active Pharmaceutical Ingredient (API) business by monitoring compliance with GMP and customer requirements across API manufacturing, and lead quality system improvement projects aligned with ISO 13485 and other medical device regulations.

CORE DUTIES:

Works with internal and external stakeholders and managers to define issues, select projects, and prioritize work. Assure projects align with business and quality system objectives. Create project charters, work plans, schedules, issues logs, and risk management plans, as necessary. Actively manages partners, contractors and/or consultants in delivering solutions during project work.
Develops project, process, instrument and product plans addressing key requirements, deliverables, timing, and assignments needed for successful completion. Write or establish methods or procedures to ensure continued and improved process and system performance. Implements project, process, instrument, or product work in collaboration with other partners, departments, or teams. Create assignments and tasks and track completion against stated requirements. Address delays and other barriers in completion of tasks.
Reports and/or presents project, instrument, or product progress/metrics to stakeholders during course of work. Identify issues detrimental to the timeline, budget, or quality of the work, and recommend solutions to overcome identified issues. Ensure source data is verified and accurate. Summarize metrics and support management to present data.
Uses quality, engineering and human factors concepts, design and implement product and process improvements to improve quality and lower costs. Ensure products and processes meet customer, business, and regulatory requirements.
Develops, redesigns, and manages processes which are compliant with customer requirements, the Quality System Regulation (QSR) and ISO13485. Key systems include Process Controls, Supplier Controls, and other related QS sub-systems.
Serves as a compliance resource for contract-manufactured Active Pharmaceutical Ingredient (API) products, monitoring adherence to API quality standards and implementing process improvements to ensure ongoing compliance with external GMP requirements and customer standards.
Supports review of nonconformance documentation for API products, as needed, to ensure compliance with internal procedures and external quality standards.
Occasionally supports customer audits, complaint resolution, and relationship development, as needed.
Use and comply with Complaint Investigation procedures and Promega's Quality System procedures as appropriate to this position. Apply problem-solving skills, while performing investigations and communicate investigational work to internal and external customers as applicable. Recommend further action, as necessary.
Works with management with executive responsibility on urgent/critical activities or projects needed for the business.
Performs other duties as assigned to support departmental and business needs.
Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

Minimum BS degree or equivalent in engineering, technical and/or scientific discipline with minimum 4 years of engineering or design experience.
Minimum of 3 years' experience in project management or supervision, especially in the biotechnology or medical device areas.
Demonstrated adaptability and willingness to learn and effectively use AI-supported tools in daily work, along with working knowledge of role-relevant software such as Visio, Microsoft Project, and CAD in a Windows-based environment.
Demonstrated experience in achieving results in a rapidly changing cross-functional environment.
Strong analytic and presentation skills for problem determination, decision-making and resolution.
Over 2 years' experience in designing, developing, and supporting biotechnology, medical device, or API product lines.
Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration.

PREFERRED QUALIFICATIONS:

Independent, self-starter with proven results in problem identification, planning, communication, and project management.
Able to work and communicate well with a diverse scientific, business, and organizational group to achieve improvement and operational results.
Experience in medical device and cGMP systems, especially in understanding requirements, identifying improvement targets, tracking results, and developing products.
Experience in Active Pharmaceutical Ingredient (API) manufacturing or contract-manufactured API compliance, including working knowledge of quality standards governing API products.
Technical knowledge or experience in scientific areas applicable to small molecule drug manufacturing.
Excellent oral and written communication skills, including formal presentations, coaching, and problem resolution.
Ability to articulate technical and interpersonal issues and resolve conflict in a constructive manner to ensure project success.
MS or greater in engineering or technical discipline.

PHYSICAL DEMANDS:

Ability to use a computer/Microsoft Office applications.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

Apply on careers.promega.com About employer

More about this job

Skills

Supply chain management
Quality assurance procedures
Regulatory compliance
Good manufacturing practices
Quality control systems
Medical device regulations
Risk management
Collaboration
Manage quantitative data
Documentation
Problem solving
Project management
Biotechnology
Adaptability
Microsoft Visio
Microsoft Project
Microsoft Windows
Presentation skills
Decision making
Communication skills
Coaching
Use a computer
Microsoft Office

Report this job

Work requirements

Jobs in the United States