- Proven experience in a Quality Control or Quality Assurance leadership role within manufacturing environments. Adhesive Background is a plus.
- Extensive knowledge of ISO 13485, ISO 9001, FDA regulations, HACCP principles, CGMP guidelines, and related quality standards.
- Demonstrated expertise in conducting quality audits and inspections.
- strong background in developing and managing quality systems and documentation processes.
- Experience with QA/QC methodologies, root cause analysis, corrective/preventive actions (CAPA), and project management.
- Excellent analytical skills with the ability to interpret complex data sets for decision-making purposes.
- Prior experience leading cross-functional teams in a regulated manufacturing setting is preferred. This position offers an opportunity to lead a dedicated team committed to excellence in product quality while supporting the company's growth through rigorous compliance and innovative quality management practices.
- Collaborate with cross-functional teams including manufacturing, engineering, and regulatory affairs to resolve quality issues promptly.
- Conduct analysis of quality data to identify trends and areas for process improvement.
- Train staff on quality systems, inspection techniques, and regulatory compliance standards.
- Lead initiatives for continuous improvement in product quality and operational efficiency through project management and analysis skills.
- Ensure adherence to safety protocols and regulatory updates affecting product quality.
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
salary: $85,000 - $100,000 per year
shift: First
work hours: 8 AM - 5 PM
education: Associate
Responsibilities
- Monitoring product quality produced .
- Summary weekly quality data (num. of inspection batch, off-spec batch %, quality issues) to HQ quality director & the site operation manager/ site president.
- Report non-conformed materials to HQ quality director & the site operation manager/ site president.
- Make corrective action report (8D report) on the non-conformed materials
- Communicate with the customer’s quality team and coordinate with relevant HQ departments to address and resolve quality issues.
- Conduct practical, hands-on inspections of manufactured products and raw materials, and manage related quality control activities.
- Support customer's PPAP approval for new developed part (Reliability test, Preparation of PPAP documents).
- Prepare & take the customer’s audit & IATF 16949 certificate audit.
- Develop, implement, and maintain comprehensive quality control and assurance programs aligned with ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and other applicable standards.
- Lead and coordinate internal and external quality audits to ensure compliance with regulatory requirements and company policies.
- Oversee quality inspection processes throughout manufacturing to identify defects or deviations from specifications.
- Manage the documentation of quality procedures, non-conformance reports, corrective actions, and validation activities.
The essential functions of this role include:
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.