• Champion compliance with applicable global regulations and quality standards (e.g., FDA QSR, ISO, EN), including support during internal and external audits
• Lead investigations, documentation, review, and approval of non-conformances, CAPAs, and customer complaints, escalating quality issues as appropriate
• Own material identification, segregation, and defect classification processes within manufacturing operations
• Analyze and assess the effectiveness of corrective and preventive actions, including root cause investigations
• Maintain and review quality metrics, including leading and lagging indicators
• Support development of validation strategies and approve IQ, OQ, PQ, TMV, and software validation documentation
• Partner with supply chain, manufacturing, and material suppliers to ensure effective process validation, process control, risk management, and resolution of process failures
• Perform statistical data collection, analysis, and interpretation to support process improvements and daily operations
• Evaluate and document process changes to ensure risk levels remain within acceptable limits and regulatory compliance is maintained

• 2-4+ years of Quality Engineering experience
• Medical Device manufacturing experience strongly preferred; Industrial Quality experience also considered
• Technical degree (Engineering or related discipline preferred)
• Strong knowledge of quality management systems and regulatory requirements (ISO 13485, FDA QSR)
• Hands-on experience with CAPAs, non-conformances, audits, and process validation
• Strong troubleshooting, data analysis, and trending skills
• Excellent communication skills with the ability to collaborate cross‑functionally
• Demonstrated ability to identify, assess, and act on quality and compliance risks
• Ability to work with urgency, accountability, and flexibility in a fast‑paced manufacturing environment

• Medical Device or Industrial Manufacturing environment experience

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.