Quality & Compliance Coach - Senior Manager

job summary:
Are you a seasoned medical device quality leader ready to drive audit readiness and mentor a dedicated manufacturing team? A leading medical device manufacturer in Reedsville, PA is seeking a high-impact Quality & Compliance Coach for a critical 6-8 month contract. If you excel at indirect influence, coaching floor staff on regulatory standards, and acting as the face of quality during major inspections, this high-visibility role offers an exceptional opportunity to shape site readiness.

location: Reedsville, Pennsylvania
job type: Contract
salary: $100.00 - 112.16 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Lead front-room and back-room regulatory audit preparation and site-wide FDA inspection readiness initiatives.
• Perform daily floor walks to audit processes, update quality procedures, and align site operations with design and process control standards.
• Coach and mentor site leadership, supervisors, and personnel on medical device quality standards and operational best practices.
• Partner with site operations leaders and regional leadership to drive sustainable compliance improvements across legal manufacturing functions.
• Serve as a senior technical quality advisor, guiding teams through indirect leadership without day-to-day administrative people management.

 
qualifications:

• 15+ years of quality engineering/management experience in medical device manufacturing (pure pharmaceutical background excluded).
• Prior experience as a Management Representative or Site Quality Leader with direct front-room exposure during FDA regulatory inspections.
• Deep technical expertise in inspection readiness, process controls, design controls, and legal manufacturing compliance.
• Proven ability to influence, coach, and build rapport with cross-functional teams without direct line authority.

#LI-CV1

skills: Corrective and Preventive Actions (CAPA), Medical Device, Food and Drug Administration (FDA), Medical Device Regulation (MDR), Quality Management Systems (QMS)




Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.




Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).




This posting is open for thirty (30) days.

Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.