Quality Specialist/Quality Engineer - Parsippany, United States - Extremity Medical
Description
Job Description
Job DescriptionSupport all aspects of quality activities within the organization as directed by the Director of QA/RA. Ensure that the requirements of the Quality System are implemented and maintained, and promote awareness of regulatory and customer requirements throughout the company.
Educational Requirements: Bachelors Degree
Experience Requirements: 3-6 years Quality Engineering experience, and at least 2 years in Medical Device. Auditing experience preferred.
Primary Job Responsibilities:
1. Develop and implement quality management system, strategy and plans to ensure compliance with FDA QSR, ISO 13485, MDD 93/42/EEC and other regulatory requirements in accordance with company goals.
2. Support the Management Representative by interacting and co-operating with government and regulatory bodies (eg BSI, FDA, etc), as necessary, during audits.
3. Monitor performance (in relevant areas) according to appropriate standards and take necessary action to communicate/advise/assist according to performance levels.
4. Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal quality management systems.
5. Report as necessary on changes in standards (internally and externally initiated) and on performance against standards.
6. Interact with customers and suppliers where necessary (where impacting/affected by quality issues)
7. Support with the preparation of data for Management Review meetings.
Secondary Job Responsibilities:
1. Coordinate the following: Corrective and Preventive Actions (CAPA), Non-conforming Material (NCMR)
2. Participate in Supplier Control activities
3. Coordinate internal and supplier audits. Conduct supplier audits.
4. Coordinate Customer Complaint and Product Surveillance activities including ensuring appropriate notification to customers and regulatory authorities. Complete complaint investigations in eQMS.
5. Lead the quality functions for new product development, design transfer and manage the completion of the design history file.
6. Create and manage a system that ensures the quality of outsourced products and services.
7. Coordinate the Risk Management System.
8. Coordinate computer system validation efforts within the organization, including the drafting of Quality plans and PQs, executing scripts, and drafting reports.
Company DescriptionExtremity Medical is an orthopedic implant and instrument company focused on fusion and motion preservation in the foot and ankle, and hand and wrist. The company sells approximately 15 product lines both in the US and internationally. The company is focused on development of novel products to meet customer needs.