Quality & Compliance Coach - Director Level

Randstad USA; Reedsville (PA); On-site; USD 138,000 - 155,000; Full time

Job summary

Randstad USA is seeking a Quality & Compliance Coach - Director Level for an 8-month engagement onsite in Reedsville, PA. You will leverage deep QMSR and ISO 13485 expertise to coach site teams, optimize QMS execution, and drive first-time-right operational performance.

Lead onsite quality walks, partner with manufacturing, engineering, and regulatory teams, and prepare teams for health authority inspections.

Qualifications

• 15+ years in FDA-regulated medical device manufacturing with focus on QMS, CAPA, and inspection readiness.
• Deep expertise in QMSR, FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Front Room and Back Room audit experience for FDA and Notified Body inspections.
• Experience as Management Representative or senior quality leader.

Responsibilities

• Lead onsite Quality Walks to reinforce process discipline and audit confidence.
• Partner with manufacturing, engineering, and regulatory teams to embed daily practices.
• Coach site leaders and SMEs on translating regulatory requirements into workflows.
• Prepare teams for health authority and Notified Body inspections, managing Front/Back Room strategies.
• Use quality data and CAPA outputs to target coaching and reduce risk.

Skills

CAPA

Medical Device

FDA

MDR

QMS

Education

Bachelor's degree

Master's preferred

Job description

Drive quality culture and continuous inspection readiness onsite in Reedsville, PA! A top-tier global medical device leader is seeking a high-caliber Quality & Compliance Coach - Director Level for an 8-month engagement. In this high-impact role, you will leverage deep QMSR and ISO 13485 expertise to coach site teams, optimize QMS execution, and drive first-time-right operational performance.

location: Reedsville, Pennsylvania

job type: Contract

salary: $100.00 - 112.16 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Lead onsite Quality Walks to reinforce process discipline, build audit confidence, and foster a proactive quality culture.
• Partner cross-functionally with manufacturing, engineering, and regulatory teams to embed sustainable, inspection-ready daily practices.
• Coach site leaders, process owners, and SMEs on translating complex global regulatory requirements into repeatable workflows.
• Prepare teams for health authority and Notified Body inspections, managing Front Room and Back Room strategies.
• Utilize quality data, nonconformances, and CAPA outputs to target coaching focus areas and reduce operational risk.

Qualifications

Required

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 15+ years of FDA-regulated medical device manufacturing experience with an extensive focus on QMS compliance, CAPA, and inspection readiness.
• Deep subject matter expertise in QMSR, FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Demonstrated Front Room and Back Room audit expertise for FDA and Notified Body inspections.
• Prior experience in a Management Representative or equivalent senior quality leadership role.

Preferred

• Master's degree in Engineering or Life Sciences.

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 [e-mail].

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.