Quality Engineer

Bihler of America Inc.; Phillipsburg (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

Bihler of America Inc. is seeking a Quality Engineer to support the quality management system across design, development, manufacture and distribution of medical devices.

You will manage document control, regulatory compliance, CAPA and risk management, coordinate sterilization activities, support validation, deliver training, and ensure audit readiness in cross-functional teams. This role requires a Bachelor’s degree in engineering and experience in ISO medical device environments with strong

Qualifications

• Bachelor’s degree in engineering or related field.
• Experience in ISO medical device environments.
• Proficiency with MS Excel and MS Word.

Responsibilities

• Maintain Quality Management System documentation and control.
• Ensure regulatory compliance (FDA 21 CFR 820, ISO 13485, ISO 14971).
• Lead CAPA investigations and effectiveness checks.
• Coordinate sterilization activities and validation support.
• Provide training and audit readiness support.

Skills

English communication

MS Excel

MS Word

Education

Bachelor’s degree in Engineering or related field

Tools

Electronic quality management system

Job description

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:

1. Possess knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)
2. Ensure compliance to QSR and GMP in assigned areas
3. Manage corrective and preventive action process from investigation through effectiveness checks
4. Maintain Design History and Technical Files, and documentation for internal and external audits
5. Organize and prioritize assigned tasks to ensure project meets expectations and timelines
6. Develop, deliver, and document departmental and companywide quality training
7. Reviews validation protocols and reports for technical adequacy, regulatory compliance, defined acceptance criteria, and complete documentation
8. Utilize Quality tools such as FMEA, Control Plan, and Process Flow
9. Background in Risk Management a plus
10. Possess competent technical writing skills
11. 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