Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
DESCRIPTION:
Join a mission-driven organization dedicated to improving human health. As a Quality Engineering Supervisor, you will support the manufacturing of medical devices and clinical diagnostic reagents that empower customers to detect disease, accelerate research, and protect patient health. Your leadership will directly contribute to delivering safe, compliant, and high-quality products that make a real-world impact.
Location: Middletown, VA.
Relocation assistance is NOT provided.
- Lead, develop, and manage a team of Quality Engineers, fostering a high-performance culture focused on accountability, growth, and continuous improvement.
- Own and drive the site quality engineering strategy aligned with business objectives, regulatory requirements, and global quality standards.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IVDR, GMP, and other applicable regulations across all quality engineering activities.
- Serve as a key quality leader partnering with Operations, Technical Operations, Manufacturing Engineering, Regulatory Affairs, and Supply Chain to ensure robust product and process controls.
- Provide oversight and final approval for critical quality system elements, including CAPAs, nonconformances, deviations, change controls, and validation activities.
- Lead complex investigations and ensure effective root cause analysis, risk assessment, and sustainable corrective/preventive actions.
- Oversee raw material qualification, supplier quality integration, and lot release processes to ensure product integrity.
- Establish and monitor quality KPIs, using data analytics to drive proactive improvements and operational excellence.
- Lead regulatory, customer, and internal audits, ensuring site readiness and successful outcomes.
- Champion continuous improvement initiatives using Lean, Six Sigma, and risk-based methodologies (FMEA, risk management).
- Drive talent development, succession planning, and organizational capability within the quality engineering function.
REQUIREMENTS
Education
- Bachelor’s degree in engineering, Life Sciences, Chemistry, Biology, or a related technical field required. Advanced degree (MBA, MS) preferred.
Experience
- 3+ years of experience in Quality Engineering within medical devices, in vitro diagnostics (IVD), or clinical reagent manufacturing.
- Proven leadership experience managing teams and driving organizational performance.
- Strong expertise in quality systems and regulations (FDA QSR, ISO 13485, ISO 14971, GMP, IVDR).
- Demonstrated success leading complex quality initiatives, investigations, and cross-functional projects.
- Experience with validation, statistical methods, and design/process controls.
- Lean Six Sigma certification or equivalent experience preferred.
Knowledge, Skills, Abilities
- Strong leadership and people development skills with the ability to influence and inspire teams.
- Strategic thinker with strong business acumen and decision-making capability.
- Advanced problem-solving skills using structured methodologies (5 Whys, Fishbone, DOE, etc.).
- Excellent communication and stakeholder management skills across all organizational levels.
- Deep understanding of regulated manufacturing environments and quality systems.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong commitment to quality, compliance, and patient safety.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
