- 208124 - Quality Assurance Engineer
- Up to $58.54 DOE
- 6 months
Chipton Ross is seeking a Quality Assurance Engineer for a contract opportunity in Acton, MA.
Complaint Investigations (Time Spent: 45%):
Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined" problem code and cause codes for each complaint.
Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues.
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
Conduct corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Support CAPA and maintenance activities for existing product lines.
Recommend and/or support projects for improvements to the quality system as approved by management.
Nonconforming Material Review Board (Time Spent: 45%):
Support material review board
Develop dispositions for nonconforming material using engineering / risk-based rationale.
Coordinate the quarantine of nonconforming material.
Communicate with suppliers about material that does not meet specification.
Other (Time Spent: 10%):
Provide quality support to various improvement projects
Perform quality duties as assigned by Quality Manager
To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.
- Knowledge and working application of reading and understanding blueprints and technical drawings.
- Demonstrated strong analytical problem solving (Root Cause Investigations).
- Computer competency in Word, Excel, Power Point
- Ability to multi-task and methodically manage projects.
- Critical thinking
- Attention to detail
- Collaboration & Teamwork
- Dealing with Ambiguity
- Strong ability to balance multiple priorities
- Medical Device Experience with knowledge of 21CFR820 preferred / ISO 13485 / FDA cGMP
- Competency in SAP
- Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
- Able to exert up to 10 pounds of force occasionally.
- Able to sit, stand, walk throughout the workday.
- 0-3 years of Medical Device experience
- Accredited Bachelor of Science degree in Engineering
First shift, full time
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x251 or (800) 927-9318 x251
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.