Quality Engineer

Quality Engineer

Bihler of America, Inc – Phillipsburg, NJ

Job Type: Full-time

Bihler of America, Inc. is a private family-owned business that started in New Jersey in 1976. We have grown into a mid-size manufacturing company but hold the small company values. We care about our employees. Come join our team! Currently we are looking for a qualified Quality Engineer.

Job 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 company wide 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

Salary:

• Pay range based on experience

We are an Equal Opportunity Employer (E.O.E). We require new hire Drug testing and Background checks.

Competitive compensation with paid Holiday, Vacation and Personal days. We also provide a 401K plan with a company match program for qualified individuals. Full benefits including Horizon Blue Cross Blue Shield Health Plans, Short & Long-Term Disability, Dental, Vision, Life Insurance and More.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Work Location: In person