About Us:
Dutch Ophthalmic USA and is part of DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.
Every single day our employees ensure that eye surgeons all over the world enjoy the use of innovative ophthalmic devices, instruments, and liquids. DORC uses cutting-edge technology, works closely with innovative surgeons, and thrives to make a difference. Ophthalmologists worldwide use our advanced Ophthalmic surgery unit EVA to take care of their patients to help them see again.
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.
Location/Region: This position will be located in New Britain, PA.
What’s the role?
Provide quality engineering support and expertise to the organization in specified location and all sites in all stages of the product life-cycle to ensure that DORC branded released product meets specifications, issues are adequately and timely resolved, and quality of product, process and supplier quality shows continuous improvement.
Sound Interesting?
Here’s what you’ll do:
1. 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.
2. Drive and support continuous improvement across the organization by providing quality engineering expertise to improve robustness of design, process and supplied material.
3. Optimize, align, and control the inspection and measurements methods (including level of inspection) and acceptance criteria across the supply chain.
4. Support of the operations, engineering and purchasing department in case non-conforming materials are detected by owning the process of non-conforming products.
5. Implementation of immediate mitigation actions in case non-conforming materials are detected.
6. With regard to CAPAs, NCs and SCARS:
7. Coordinate and support root cause investigations.
8. Prevent reoccurrence of quality issues.
9. Monitoring progress in corrective action implementation.
10. Verify that corrections and corrective actions are effective.
11. Ensure documentation on NCs and SCARs is complete at closure.
12. Provide periodic reporting and trending.
13. Ensure that suppliers used by DORC have the capabilities to meet DORC requirements and are selected, qualified, evaluated and maintained per internal procedures.
14. Maintain relationship with and oversight on suppliers through periodic visits and execution of supplier audits.
15. Drive efforts to increase the maturity of the internal organization as well as suppliers.
Do you qualify?
16. Bachelor’s degree (or equivalent ability) in relevant technical field.
17. Minimally 3 years in quality engineering in a regulated environment.
18. Knowledge of mechanical, plastics and/or electrical parts and their manufacturing methods.
19. Understanding of quality system requirements (ISO9001, ISO13485 or similar).
20. Relevant experience in quality engineering in product development, production, and/or supplier management.
21. Experience in conducting audits preferably against ISO13485 standard.
22. Experience in participating in and/or leading quality improvement projects.
23. Understanding of and experience with inspection and measurement methods and/or other concepts to assure quality of materials and product.
24. Understanding of the application of statistics in quality control.
25. Fluent English (written and spoken).
26. Advanced level in Microsoft Office suite applications.
27. Ability to self-motivated and work independently in a geographically separated multi-national and multi-functional team environment.
28. Collaborates effectively in international cross-functional teams.
29. Communicate actively with production engineers
30. Open minded for improvement opportunities and change towards striving for best-in-class compliance performance.
31. High level of integrity and ethical standards.
32. Ability to think creatively, proactively identifying alternative solutions to problems.
33. Good communication/interpersonal skills.
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
• up to 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.
• Variable Compensation program
Your ZEISS Recruiting Team:
Debra Ann Rybolt, Jo Anne Mittelman