Quality Assurance Engineering Manager

Prospect Life Sciences; Denver (CO); On-site; USD 120,000 - 160,000; Full time

Job summary

Prospect Life Sciences in Denver, CO seeks a Quality Engineering Manager to own and advance the Quality Management System, ensuring compliance with FDA QSR, ISO standards, and product lifecycle requirements.

You will lead cross-functional teams, drive audits, process improvements, and supplier and internal quality programs while collaborating with senior leadership.

This role emphasizes scalable quality systems, risk management, and the integration of AI-enabled automation to support growth.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 8+ years in FDA-regulated medical device QMS.
• Experience implementing QMSR, ISO 13485:2016, ISO 14971.
• Experience leading audits (internal, supplier, process).
• Ability to lead cross-functional teams and manage quality performance.

Responsibilities

• Provide strategic leadership for the QMS and ensure regulatory compliance.
• Lead audits, risk management, design controls, and manufacturing readiness.
• Drive continuous improvement and scalable quality systems.
• Collaborate with CEO/Head of Product Development and Operations.
• Oversee client programs and quality deliverables.

Skills

Leadership

Cross-functional leadership

Quality systems

Regulatory compliance

Project management

Audits

Process improvement

AI-enabled automation

Education

Bachelor's degree

Job description

Summary

The Quality Engineering Manager is directly responsible for creating, updating, and maintaining quality system documents. They will be expected to review, approve, and implement changes to quality system documents and records produced by document control, production, product development, and incoming inspection.

The position reports directly to the CEO/President.

Key Accountabilities

Quality System Functional Group Ownership - 60%

Accountable for providing strategic leadership and operational ownership of the Quality Management System (QMS), ensuring regulatory compliance, process effectiveness, continuous improvement, and cross‑functional quality support throughout the product lifecycle. Responsible for establishing functional objectives, developing personnel, managing quality performance, and driving scalable quality systems that support company growth.

Prospect Life Sciences / Operating System Responsibilities - 10%

Accountable for implementing and sustaining the Prospect Life Sciences Operating System (OS) within the Quality organization by developing associates, driving organizational accountability, supporting strategic initiatives, monitoring key performance indicators, and ensuring Quality objectives are aligned with company Vision, Traction, and organizational goals.

Client Project Responsibilities - 30%

Accountable for providing Quality Engineering leadership for assigned client programs by ensuring manufacturing processes, validation activities, quality deliverables, regulatory compliance, project schedules, budgets, and client expectations are successfully achieved while fostering long‑term client relationships and continuous process improvement.

Primary Responsibilities

Quality System Functional Group Ownership

• Responsible for owning and leading the Quality System core processes, including vision, objectives, compliance, best management practices, and adherence to the QMS.
• Responsible for ensuring all Quality associates have performance and development plans that support continuous improvement and functional excellence.
• Responsible for maintaining and continuously improving Quality System processes through internal and external audits and ongoing compliance activities.
• Responsible for ensuring the Quality functional group provides effective cross‑functional support through compliance guidance, quality oversight, risk management, design controls, and manufacturing readiness.
• Responsible for improving Quality System efficiency and scalability through the implementation of best practices, new tools, and AI‑enabled automation.
• Acting QSMR responsible for leading management reviews and audits with external parties including clients, registrar, and FDA inspections as applicable.

Prospect Life Sciences / Operating System Responsibilities

• Responsible for maintaining and completing my PEEP reviews on a quarterly basis.
• Responsible for attending, actively participating in, and providing content for NPI Manufacturing Transfer and Quality Operating System (OS) meetings.
• Responsible for reporting, tracking, and contributing to Manufacturing Transfer and Quality KPIs on a weekly basis, including accurate time tracking.
• Responsible for evaluating, developing, and coaching my direct reports to ensure role alignment, performance effectiveness, and readiness.
• Responsible for actively implementing EOS across all six components and supporting cross‑functional understanding and adoption of the system.
• Responsible for reinforcing organizational values through role modeling, coaching, and accountability.
• Responsible for collaborating with the CEO, Head of Product Development, and Operations to update, maintain, and execute against the company VTO.
• Actively pursue self‑initiated professional development opportunities beyond PLS-sponsored programs to enhance leadership, technical capability, and organizational impact.

Client Project Responsibilities

• Responsible for delivering assigned client projects on time, within budget, and in compliance with regulatory and contractual requirements.
• Responsible for completing EOM/PRs and ensuring accurate invoicing for my projects by the first business day of each month.
• Responsible for supporting existing client proposal development by contributing technical input, reviewing deliverables, supporting budgeting, participating in client Q&A, and reviewing proposals with the CEO to support the BD pipeline.
• Responsible for conducting process implementation and validation retrospectives for client projects, when applicable.
• Responsible for proactively seeking and incorporating client feedback to support personal performance improvement and PLS continuous improvement efforts.

Education and Experience

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum of eight (8) years of progressive experience in FDA-regulated medical device Quality Management Systems.
• Demonstrated experience implementing, maintaining, and improving Quality Management Systems compliant with the FDA Quality Management System Regulation (QMSR), formerly 21 CFR Part 820 (QSR), ISO 13485:2016, ISO 14971, and other applicable domestic and international regulatory requirements.
• Experience planning, conducting, and reporting internal, supplier, and process audits.
• Qualified, or capable of becoming qualified within six (6) months of hire, as a PLS Internal Quality Auditor in accordance with ISO 13485:2016 and the PLS Internal Audit Procedure.
• Demonstrated leadership experience supervising Quality personnel and leading cross‑functional teams.

Preferred Qualifications

• Experience working in a Contract Development and Manufacturing Organization (CDMO).
• Experience with electronic Quality Management Systems (QMS) and ERP systems.Experience implementing Lean, Six Sigma, EOS, or other continuous improvement methodologies.
• Excellent leadership, technical writing, communication, organizational, and project management skills.

Preferred Professional Certifications

• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) (preferred for management positions)
• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)
• ISO 13485:2016 Lead Auditor or Internal Auditor Certification
• Medical Device Single Audit Program (MDSAP) Auditor Training