193691 - QA Specialist 3
CA-Central California
Up to $48.00 DOE
5 mos
Chipton-Ross is seeking a QA Specialist for an opening in Pleasanton, CA.

The role of the Quality Specialist is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services. The Quality Specialist will work with various team members and internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments.

As a QA Specialist, you will help to ensure the Pleasanton site meets all the requirements for ISO 13485 and 21CFR820. You will partner with various Quality, Regulatory and Technical teams to address customer complaints.

Write, review and process customer complaint investigations for medical device. Collect relevant information from regulatory, technical and customer facing teams for investigation and complaint documentation. Write and process customer complaint investigation in complaint system. Help with final review and approval of complaint investigations.

Experienced in documenting and processing complaints for medical device
Experience working under ISO 13485, 21CFR820 (cGMP) 5+ years of work experience in Quality Assurance/Quality Systems role. Experienced in using Trackwise (strongly preferred). Strong computer skills (Office, Teams, Word, Excel). Experienced with Quality tools and methodologies including investigation/root cause analysis. Must be self-motivated, proactive, organized, and detail oriented. Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet regulatory and business requirements. Solid organizational and time management skills to meet deadlines. Highly energetic, positive attitude, and works well under stress. Excellent communication and interpersonal skills with the ability to interact with all levels of the organization both orally and in writing. Strong track record of working cross functionally.

Accredited Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences.

Hours: 8 - 5

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Brenda Ordaz
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x284 or (800) 927-9318 x284

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.