For more than 80 years, our client’s engineers and product specialists have partnered with customers to produce highly engineered connectivity and sensing solutions that make a connected world possible. Their focus on reliability, durability, and sustainability exemplifies their commitment to progress. The unmatched range of their product portfolio enables companies, large and small, to turn ideas into technology that can transform how the world works and lives tomorrow.
Responsibilities:
- Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.
- Supervise and manage the incoming and final inspection areas.
- Drive improvement initiatives within incoming, in-process, and final inspection operations.
- Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&Rs.
- Identify and execute containment actions for nonconforming materials found during in-process or final inspections.
- Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.
- Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.
- Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).
- Create and update operations procedures and documentation used within production.
- Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.
- Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.
- Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.
- Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.
Requirements:
Qualifications/Background:
- Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).
- Prior experience as a Quality Engineer in a manufacturing environment.
- 5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.
- Supervisory or management experience preferred.
- Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.
- Excellent written and verbal communication skills.