Quality Engineer

D.O.R.C. Dutch Ophthalmic Research Center (operating as DORC); Seabrook (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical – 90% employer paid

Dental – 100% employer paid

Life Insurance, AD&D, STD & LTD – 100%

Vision benefits

401k Matching

Paid Leave: Sick, Vacation and HOLID.

Job summary

Dutch Ophthalmic USA, Inc. and its subsidiaries seek a Quality Engineer to ensure manufacturing operations meet quality and regulatory standards.

You will provide hands-on production support, collaborate with Manufacturing Engineering, and serve as backup for quality functions to ensure consistency and compliance. The role involves process validation, design transfer, inspections, and CAPA investigations across Exeter & Seabrook, NH, and New Britain, PA sites.

Qualifications

• Four-year engineering degree is required.
• 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.

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.).

Skills

ISO 13485

GMP Experience

Computer proficiency

MS Office

Analytical skills

Communication skills

AutoCAD

SolidWorks

ERP experience

Microscope experience

Education

Bachelor's degree in engineering

Master's degree in technical field

5–10 years related experience

Quality Engineering in medical device

Tools

ERP systems

Job description

Did you know ...?

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.

What is the role?

The Quality Engineer ensures manufacturing operations meet established quality and regulatory standards across three entities. This role provides hands‑on production support, collaborates closely with Manufacturing Engineering, and serves as backup for all quality‑related functions to ensure consistency and compliance.

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.).

Education and Experience

• 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.

Skills, know-how and experience:

• 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.

This is a full-time, onsite opportunity with travel up to 15% travel across three sites, Exeter & Seabrook, NH & New Britain, PA.

We have amazing benefits to support you as an employee at Dutch Ophthalmic!

• Medical – 90%employer paid
• Dental – 100% employer paid
• Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
• Vision
• 401k Matching
• Paid Leave: Sick, Vacation and Holidays
• The list goes on!

WillyoubeournewQuality Engineer?

Dutch Ophthalmic 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.