Quality Assurance Engineer - Medical Device Manufacturing
About The Position
Ensure that protocols, reports, and records created as part of product and process development as well as changes in products and processes are critically independently reviewed for content and compliance Drive and support continuous improvement across the organization by providing quality engineering expertise to improve robustness of design, process and supplied material Optimize, align, and control the inspection and measurements methods (including level of inspection) and acceptance criteria across the supply chain Support of the operations, engineering and purchasing department in case non-conforming materials are detected by owning the process of non-conforming products Implementation of immediate mitigation actions in case non-conforming materials are detected Coordinate and support root cause investigations Prevent reoccurrence of quality issues Monitoring progress in corrective action implementation Verify that corrections and corrective actions are effective Ensure documentation on NCs and SCARs is complete at closure Provide periodic reporting and trending. Ensure that suppliers used by DORC have the capabilities to meet DORC requirements and are selected, qualified, evaluated and maintained per internal procedures. Maintain relationship with and oversight on suppliers through periodic visits and execution of supplier audits. Drive efforts to increase the maturity of the internal organization as well as suppliers.
Requirements
- Bachelor’s degree (or equivalent ability) in relevant technical field required. Master's degree preferred.
- Minimum 3 years in quality engineering in a regulated environment
- Knowledge of mechanical, plastics and/or electrical parts and their manufacturing methods
- Understanding of quality system requirements (ISO9001, ISO13485 or similar)
- Relevant experience in quality engineering in product development, production, and/or supplier management
- Experience in conducting audits preferably against ISO13485 standard
- Experience in participating in and/or leading quality improvement projects
- Understanding of and experience with inspection and measurement methods and/or other concepts to assure quality of materials and product
- Understanding of the application of statistics in quality control
- Fluent English (written and spoken)
- Ability to work independently in a geographically separated multi-national and multi-functional team environment
- Collaborates effectively in international cross-functional teams
- Communicate actively with production engineers
- Open minded for improvement opportunities and change towards striving for best-in-class compliance performance
- High level of integrity and ethical standards
Nice To Haves
- Master's degree preferred.
Responsibilities
- Ensure that protocols, reports, and records created as part of product and process development as well as changes in products and processes are critically independently reviewed for content and compliance
- Drive and support continuous improvement across the organization by providing quality engineering expertise to improve robustness of design, process and supplied material
- Optimize, align, and control the inspection and measurements methods (including level of inspection) and acceptance criteria across the supply chain
- Support of the operations, engineering and purchasing department in case non-conforming materials are detected by owning the process of non-conforming products
- Implementation of immediate mitigation actions in case non-conforming materials are detected
- Coordinate and support root cause investigations
- Prevent reoccurrence of quality issues
- Monitoring progress in corrective action implementation
- Verify that corrections and corrective actions are effective
- Ensure documentation on NCs and SCARs is complete at closure
- Provide periodic reporting and trending.
- Ensure that suppliers used by DORC have the capabilities to meet DORC requirements and are selected, qualified, evaluated and maintained per internal procedures.
- Maintain relationship with and oversight on suppliers through periodic visits and execution of supplier audits.
- Drive efforts to increase the maturity of the internal organization as well as suppliers.
Benefits
- 3 weeks of vacation (accrued)
- 10 sick days annually (prorated for new hires)
- 10 US holidays
- 90% of Health Insurance premiums paid by the company.
- Dental & Vision coverage
- 401k plan with company match
- Paid short term, long term & basic life insurance paid by the company.
- Bonus program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
