- 193835 - Jr Quality Engineer
- CA-Southern California - San Diego
- San Diego
- $31.25 to $36.05 DOE
- 5 mos
- Chipton-Ross is seeking a Jr. Quality Engineer for an opening in San Diego, CA.
This position will be responsible for support of on-going commercial medical device and reagent production activities. Support new product launches, scale up, and continuous improvements through production lines installation and qualification.
Develop/ Write/Oversee IQ/OQ/PQ and PVs for Manufacturing Equipment and Processes. Perform investigations and complete action items for open CAPAs. Complete accurate and timely manufacturing documentation including manufacturing procedures, inspection procedures, materials records, etc. Develop new test methods and perform test method validation in compliance with FDA and ISO requirements. Other duties as assigned; as emerging growth company, it may be required from time to time to assist in other areas other than the area of specialty. Support internal and external audits for compliance to ISO 13485 and FDA standards.
2-5 years’ experience working in FDA and ISO 13485 regulated company. 2-5 years’ experience in biotech / IVD / Medical Device. Experience with medical device manufacturing processes qualification (IQ/OQ/PQ). Product manufacturing, inspection, and testing experience. Good working knowledge of manufacturing equipment. Good written and verbal communication skills. Ability to resolve issues quickly and recommend preventive solutions. Strong knowledge of statistical analysis. Strong GMP and GDP knowledge. Knowledge of MS office suite. Working knowledge of 13485:2016.
Ability to work long hours and execute under pressure with short turnaround times. Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc. Available nights, weekends, and holidays when needed.
Accredited BS required, preferred in Engineering or relatable field.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x246 or (800) 927-9318 x246
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.