QMS Analyst

Job#: 3037327

Job Description:

QMS Analyst

Location:

Burlingame, California (Onsite)

Role Overview

As a Quality System Analyst, you will have a critical role in bringing medical device compliance to AR/VR products. You will support product programs by executing and implementing Standard Operating Procedures, Work Instructions, and Records from product concept through obsolescence. This role requires knowledge of regulated environments such as ISO 13485 and US FDA QSR/820, and the ability to operate with minimal supervision.

Key Responsibilities

* Support Quality Management System needs, including document management, nonconformance, CAPA, supplier qualification, process monitoring, internal audits, and medical device product complaint management.

* Create and release quality system SOPs, WIs, Templates, and records to support business needs for new product introduction and sustainment.

* Ensure documentation and data related to Quality System requirements are controlled to maintain integrity and accessibility.

* Communicate quality system requirements between Operations, Supply Chain, and Engineering to facilitate compliance with applicable medical device standards.

* Maintain all applicable records such as validation reports, test reports, exit reviews, and test results as defined by regulations and standards.

* Support audits by external bodies for licensure and accreditation document submission.

* Manage and organize complex projects and priorities, solve problems impacting release progress, and provide detailed information to cross-functional teams.

* Support the implementation of a new eQMS.

Required Qualifications

* 5+ years of related experience in a high-tech, fast-paced, consumer electronics environment managing medical device Quality Management System documentation and records.

* Experience with Teamcenter or related PLM/Document Management systems.

* Experience working in 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 Clearly Rateds 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.  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.

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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 Support Linc 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.

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