Quality Engineer

ZEISS•Seabrook, MD

23d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

Auto CAD, Solid Works, ERP experience is a plus.
Experience working under a microscope is a plus.

Responsibilities

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.