Quality Engineer

Quality Engineer

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 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 Seabrook, NH and is an onsite role.

What's the Role?

The Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards. This position works very closely with the Manufacturing Engineering team, is directly involved in day-to-day production processes, and can act as a backup for all quality-related responsibilities.

Here's what you'll do:

• Identify and assist with process validation activities.
• Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
• Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
• Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
• Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
• Inspect product including labeling and documentation for release of finished goods.
• Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs
• Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
• Oversee creation and review of documentation for nonconforming products.
• Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
• Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed
• Keep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.
• Assist with revisions and updates to quality procedures, standardized work instructions
• Participate in supplier management activities. Identify supplier quality issues and report to management in timely manner.
• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).
• Other duties as assigned.

Do You Qualify?

• Must have a four-year engineering degree.
• Bachelor's or Master's Degree in a technical area.
• 5–10 years related experience.
• Minimum of 4 years of work experience in a Quality Engineering role within a manufacturing environment in the Medical Device preferred.
• ISO 13485 and GMP Experience.
• High proficiency in computer technology and systems operations.
• Strong knowledge of Microsoft Office applications.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Auto CAD, Solid Works, ERP experience is a plus.
• Experience working under a microscope is a plus.

Your ZEISS Recruiting Team:

Debra Ann Rybolt, Jo Anne Mittelman

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).