Job#: 3045579 Job Description: Apex Systems is seeking a Quality System Analyst to support a clients Hearing Enhancement and wearable technology programs. This role will focus on post-market surveillance (PMS), complaint investigations, and customer quality activities supporting regulated products. The ideal candidate will have experience handling product complaints, conducting root cause investigations, supporting CAPA activities, and working within a Quality Management System in a regulated environment.
- Job Title: Quality System Analyst
- Contract Length: 12 months
- Pay Rate: $35-$40/hr
- Location: Burlingame, CA (onsite, relocation considered)
Job Overview:
As Quality System Analyst, you will take on a critical role in bringing medical device compliance to our AR/VR products. You will work side-by-side with quality, engineering and business teams that are leading innovation in this exciting new product category.
The Quality System Analyst will support product programs by executing / implementing Standard Operating Procedures, Work Instructions, and Records from product concept through obsolescence. The Quality System Analyst has knowledge and experience working in regulated environments (i.e. ISO 13485, US FDA QSR/820) and sufficient knowledge and experience to be able to operate with minimal supervision. You are flexible, responsive, detail oriented, hands-on and able to manage competing demands.
Responsibilities:
Support Labs Quality Management System quality system needs, including the execution of processes such as document management, CSV processing, nonconformance, CAPA, supplier qualification and monitoring, process monitoring, internal audits and medical device product complaint management.
Create and release complaint quality system SOPs, WI, Templates and records based to support business needs for new product introduction and product sustainment.
Ensure documentation and data related to the requirements of the Quality System are controlled in a manner which ensures integrity and accessibility
Collaboratively communicate quality system requirements between Operations, Supply Chain and Engineering to facilitate compliance to applicable medical devices standards
Maintenance of all applicable records such as validation reports, test reports, exit reviews, test results, as defined by applicable regulations and standards
Support audits by external bodies for licensure and accreditation documents submission
Manage and organize complex projects and priorities, solve problems that impact release progress and provide detailed information to cross functional teams
Support the implementation of new eQMS
Minimum Qualifications
5+ years of related experience in a high tech, fast paced, consumer electronics environment managing medical device Quality Management System documentation and resulting records
Experience with Teamcenter or related PLM/Document Management systems
Experience working on a regulated Medical Device environment
Familiarity with Google Suite
Familiarity with ISO 13485
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Everforth Apex uses a virtual recruiter as part of the application process. Click for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at
Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at or . Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.
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