Oversee our Quality Department and maintain our ISO 13485 QMS. You will drive compliance, continuous improvement, and operational excellence in a fast-paced plastics and medical device manufacturing environment.
Key Responsibilities
- QMS & Compliance: Maintain ISO 13485 compliance and lead all internal/external audits.
- Team Leadership: Manage, train, and develop the Quality Department team.
- Continuous Improvement: Drive root-cause analysis (CAPA, 8D, 5 Why) and track quality metrics.
- Operations: Support APQP, PFMEA, validation, and manage supplier/customer quality issues.
- Required: Active experience with ISO 13485 compliance.
- Experience: 7–10 years in medical device/plastics manufacturing quality; 5+ years in a leadership role.
- Skills: Proficient with core tools (PPAP, FMEA, SPC, MSA).
- Education: Bachelor’s degree in Engineering/Quality or equivalent experience.
salary: $120,000 - $140,000 per year
shift: First
work hours: 7 AM - 4 PM
education: Bachelors
Responsibilities
Key Responsibilities
- QMS Management: Maintain and continuously improve the ISO 13485 QMS and serve as the Management Representative to executive leadership.
- Auditing & Compliance: Lead internal, customer, supplier, and certification audits while ensuring all procedures, work instructions, and document control processes are strictly maintained.
- Team Leadership: Oversee all Quality Department activities, including hiring, training, development, and performance management.
- Continuous Improvement: Monitor quality performance indicators (scrap, rework, nonconformances) and drive structured root cause investigations using methodologies like 8D, 5 Why, and CAPA.
- Operational Support: Participate in cross-functional activities including APQP, PFMEA, control plans, and validation activities, utilizing SPC and MSA tools.
- Supplier & Customer Relations: Develop supplier quality programs and promptly respond to customer concerns and corrective action requests
Skills
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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 HRsupport@randstadusa.com.
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.
