Quality Engineer

Job in Phillipsburg, Warren County, New Jersey, 08865, USA

Listing for: Bihler of America Inc.

Full Time position
Listed on 2026-10-19

Job specializations:

Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist

Salary/Wage Range or Industry Benchmark: 85000 - 125000 USD Yearly USD 85000.00 125000.00 YEAR

Description:

The Quality Engineer supports the effective implementation and maintenance of the Quality Management System for the design, development, manufacture, and distribution of medical devices. The position is responsible for document control, regulatory compliance, CAPA, risk management, sterilization coordination, validation support, training, and audit readiness.

Preferred Qualifications:

Possess knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)

Ensure compliance to QSR and GMP in assigned areas

Manage corrective and preventive action process from investigation through effectiveness checks

Maintain Design History and Technical Files, and documentation for internal and external audits

Organize and prioritize assigned tasks to ensure project meets expectations and timelines

Develop, deliver, and document departmental and company wide quality training

Reviews validation protocols and reports for technical adequacy, regulatory compliance, defined acceptance criteria, and complete documentation

Utilize Quality tools such as FMEA, Control Plan, and Process Flow

Background in Risk Management a plus

Possess competent technical writing skills

Knowledge of medical device sterilization qualification and maintenance preferred

Qualifications:

Education:

Bachelor’s Degree in Engineering or related field of study

Skills/Licensure:
Proficiency with Microsoft applications, including Excel and Word, and the ability to learn electronic quality and document-management systems, proficiency in communicating (verbal and written) in English

Experience:

Equivalent work experience in an ISO regulated/Medical Device related background

Physical Demands:
Standing/Sitting, working at computer for normal periods

Contacts:
Works cross-functionally with Engineering, Manufacturing, and other personnel; may also interact with customers, suppliers, auditors, and regulatory representatives