We are seeking a dedicated and experienced Quality Engineering Supervisor to drive and maintain the highest standards of product quality and regulatory compliance within our medical device manufacturing operations.
Requirements
- Monitor and test the quality of products and processes in manufacturing environments, ensuring compliance with established standards and specifications.
- Ensure adherence to GMP (21 CFR 820) and ISO 13485 quality system requirements throughout all quality engineering activities.
- Respond to day-to-day production and customer quality issues related to production lines, resolving problems associated with process errors and non-conforming parts.
- Facilitate and promote the use of appropriate problem-solving techniques for effective root cause analysis and successful corrective and preventive actions (CAPA).
- Analyze customer complaints and conduct appropriate investigation to increase customer satisfaction
- Utilize statistical knowledge, including sampling plans, control charts, Design of Experiments (DOE), and ANOVA, for process monitoring, improvement, and problem-solving.
- Conduct data mining, trend analysis, and present findings to identify areas for quality improvement and risk mitigation.
- Perform and support internal quality audits to ensure compliance with regulatory requirements and company standards.
- Manage and oversee quality aspects of contract manufacturers and other suppliers
- Develop and maintain excellent technical documentation, including support for CE marking activities.
- Collaborate effectively with cross-functional teams, demonstrating excellent interpersonal skills, self-motivation, and a proactive approach to quality assurance.
- Oversee and mentor a team of Quality Technicians, providing guidance, training, and performance feedback to ensure effective execution of quality control activities and adherence to established procedures.
Benefits
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
