Quality Assurance Engineer - Medical Device Manufacturing
Quality Assurance Engineer - Medical Device Manufacturing
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Salary Not Disclosed
1 Vacancy
Job Description
As aQuality Engineeryou provide quality engineering support and expertise in all stages of the product life-cycle to ensure that Peregrine and DORC branded products meets specifications issues are adequately and timely resolved and quality of product process and supplier quality shows continuous improvement.
Location: This position is on-site at our New Britain PA production facility.
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.
Skills know-how and experience:
- Bachelors degree (or equivalent ability) in relevant technical field required. Masters 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
What does Peregrine Surgical have to offer you
Peregrine Surgical LLC is part of the Dutch Ophthalmic Research Center - a Zeiss Company; we value our employees and provide top tier benefits. Youcan expect the following:
- 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
Did you know ...
DORC short for Dutch Ophthalmic Research Center manufactures equipment instruments and liquids used in eye surgery.
DORC is a ZEISS company an internationally leading technology enterprise that develops manufactures and sells highly innovative products and solutions in a variety of business fields such as medical technology. As a company wholly owned by a foundation ZEISS is rooted in and committed to responsibility in all its activities...
WillyoubeournewQuality Assurance Engineer
AreyouupforthisThenapplytoday! DoyoustillhavequestionsThencontact Monique Christy Human Resources:
Carl Zeiss Meditec USA Inc and its subsidiariesprovide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.
Employment Type
Full-Time
