Quality Engineer
Confidential
Boone, NC
Full-time
Quality Control
Posted on July 22, 2022
We're looking for team players with a can-do attitude to share in our vision and corporate values. Pneuma Respiratory Inc. offers competitive salaries, a comprehensive benefits package, and an energetic work environment.
Currently, we are searching for a Quality Engineer to join our company located in Boone, NC.
Job Summary:
The Quality Engineer position performs duties to support the company’s quality objectives and to ensure compliance to the Quality Management System. The position will be focused on risk management and process implementation and answers to the Director of Quality.
Responsibilities/Duties:
- Create, modify and implement quality systems and procedures.
- Ensure compliance to all applicable Quality Management Systems (QMS) company wide and provide appropriate oversight at contract manufacturers’ premises.
- Perform internal audits of the quality system and verification activities, and supplier audits as requested.
- Enable Part 11 compliant document control systems.
- Provide quality and reliability engineering functions on product development projects (per ISO 13485:2016 and FDA requirements).
- Develop control plans which define verifications during production to ensure all stated requirements are met.
- Participate in ISO 14971 required risk analysis.
- Perform root cause analysis on any nonconforming material or problems that arise during product design.
- Summarize and report nonconformance information and evaluate trends and major causes.
- Plan and document studies of test method repeatability and reproducibility.
- Any other responsibilities assigned by superiors.
Qualifications:
- BS in an engineering discipline or in an equivalent science subject.
- Quality assessment/audit experience is desirable.
- 4-5 years of experience in Quality Engineering for medical devices or pharmaceutical inhalation dosage form products.
- Knowledge and understanding of ISO 13485 and FDA 21 CFR Part 820.
- Technical skills must include statistical analysis and report writing.
- Strong analytical and problem-solving skills.
- Excellent verbal and written communication skills.