Quality Engineer - Medical Device - Addison
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The Quality Engineer will be responsible for maintaining company QMS and leading all internal audit, quality control, and standards for regulation requirements such as ISO 13485 and FDA. This role will also require interaction with the customer in order to help improve quality control and lead the development of CAPAs for new/future programs in CNC manufacturing for medical devices.
Our client is a leading manufacturer for precision machined medical devices supporting large medical OEMs. Based in Elhmusrt and another location in Kenosha, the company has over a 120 employees currently and continuing to expand their team with new business. Our client takes pride in having a collaborative work environment while providing the opportunity to develop new skills and gain industry leading experiences.
Reporting directly to the Director of Quality, the Quality Engineer will be apart of a team of 3 to help drive quality control standards, external regulations, and improve customer projects. Specific responsibilities and duties include:
- Performs Internal Audits of the Quality Management System to ensure compliance to procedural, customer, and regulatory requirements
- ISO 13485
- Drive Corrective and Preventative Action plans (CAPAs) to improve or minimize customer quality open issues
- Develop root cause analysis methods and implement control plans for manufacturing teams
- Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.
- Provides inspection activity for product throughout production cycle.
- Applies total quality management tools and approaches to analytical and reporting processes within each department.
- Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
- Works with suppliers to insure quality of all purchased parts for company use.
- Design and implement quality control training programs to key personnel in conjunction with managers.
- Investigates and adjusts customer complaints regarding quality.
In return for a competitive package, the successful candidate will possess the following:
- Bachelors degree
- 3+ years of experience in quality control and engineering in manufacturing
- ISO 13485 audit training or responsibilities pertaining to audit process
- Knowledge of FDA regulations
- Experience with CAPA implementation and control plan
- Technical understanding and involvement with PPAPs
- Exposure to CNC machining and manufacturing
- Preferred industry knowledge of medical device or aerospace
A strong Quality Engineer will receive a compensation package that includes the following:
- Base salary between $70,000-$90,000 (depending on experience)
- 401(k) match
- Comprehensive health care benefits (effective day 1)
- Competitive PTO and 9 Holidays
- Clear growth and career progression