Job Title: Quality Engineer
Company: Medical Device Manufacturer
Compensation: $65k - $90k
Location: New Hampshire
- Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Lead generation and completion of protocols and reports for test method validations
- Participate in plant CAPA activities, including analysis of data and tends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
- Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies
- Works with suppliers, management, Engineers, and Manufacturing associates in the resolution of quality problems. Alo assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypothesis testing, etc.
- Associates Degree in Engineering or related field. Bachelor's degree strongly preferred.
- 2-5 years of Quality Engineering Experience, preferable in medical device.
- Competence in the selections and use of Quality Engineer Tools and Techniques.
- Good knowledge in the interpretation and application of relevant Domestics and International Regulations and Industry Standards (ISO, QSR, UL, MDD, TGA, etc.)