Quality Assurance Engineer - Medical Device Manufacturing

Full-time

Description

As a Quality Engineer you 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.

Requirements

Skills, know-how and experience:

• 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

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. You can 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...

Will you be our new Quality Assurance Engineer?

Are you up for this? Then apply today! Do you still have questions? Then contact Monique Christy, Human Resources: [email protected].

Carl Zeiss Meditec USA, Inc and its subsidiaries provide 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.