Job Description
Job#: 3036489
Job Description:
The Post Market Quality Technician plays an integral role in our client's Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals. Responsibilities:
Perform moderately complex tasks to ensure compliance with quality standards Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA Perform product testing and failure analysis Review Lot Acceptance records and DHRs Collect log quality data and trend results Accountability for quality data entry and productivity Assist in gathering information during FDA and ISO 13485
inspections Trouble shoot new failure modes. Evaluate process and engineering controls to improve safety and efficiency. Perform other duties as assigned. Education and Experience:
Minimum Requirements:
Associates Degree in an engineering, or scientific discipline Preferred Skills and Competencies:
Electrical and mechanical background strongly preferred Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred Preferred 2 years in a Quality related function, working with QSR and/or ISO 13485
Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus Ability to organize and complete tasks with minimal supervision Excellent technical writing skills Excels at generating and maintaining organized and accurate records Experience with Lean Six Sigma methodology a plus Physical Requirements (if applicable): Sitting 70%, Standing 30% Frequent lifting Occasional ( Ability to operate basic hand tools NOTE:
This position requires on-site working arrangements (requires on-site office/plant/lab work). 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. UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.
