{"id":1816620,"url":"https://alion.io/job/biomerics-quality-engineer","title":"Quality Engineer","company":{"id":3854448,"name":"Biomerics","domain":"biomerics.com","url":"https://alion.io/company/biomerics","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Brooklyn Park, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":102000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2884},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-09-16T16:16:39Z","employer_posted_date":"2026-10-04","last_verified_at":"2026-10-06T17:36:31Z","board_verified":false,"closed_at":"2026-10-06T17:36:31Z","days_open":20,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":20},"description":"Description\nBiomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.\nAt Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.\nAt Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.\nJob Description\nWe are seeking a Quality Engineer to oversee key quality functions including CAPA, Nonconforming Material, Document Control, and Training programs. This role will serve as a Subject Matter Expert, drive system improvements, and support internal audits. The specialist will collaborate with cross-functional teams to ensure compliance with product and quality requirements, support new product introduction, and assist in process and inspection development.\nResponsibilities\nDirect oversight of the Nonconforming Material and Corrective and Preventive Action system.\nDirect oversight of the Direct and Indirect Labor Training program.\nOwnership of the document control quality management system.\nInitiate and drive improvements to systems supported by this role.\nAct as primary Subject Matter Expert on systems supported by this role.\nParticipate as backup Internal Auditor as time permits.\nWork with cross functional teams to develop or improve quality systems related to standards and current business needs.\nParticipate on Manufacturing Engineering/Operations teams to assure customer product requirements as well as quality requirements are documented and addressed.\nInterface with customer on labeling design, development, and packaging considerations.\nCollaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.\nWork with Manufacturing Engineering, Operations and QC Inspection in the development and qualification of processes.\nAssist with the development of inspection processes and equipment if and when required.\nWork with R&D, Manufacturing Engineering, Operations, and Quality, during concept, prototyping, and transfer of new products into production.\nOther assignments as requested.\nRequirements\nBachelor’s Degree/Technical Degree in applicable field or equivalent industry experience\nMinimum 3 years’ experience in a Medical Device manufacturing/product development environment\nWorking knowledge of FDA QSR’s, ISO 13485, and ISO 14971 requirements\nExperience with Nonconforming Material, Corrective and Preventive Actions, Training for both Direct and Indirect Labor, and working knowledge of Quality Management System software.\nExperience/knowledge with product/process verifications/validations\nExperience with development and support of Quality Systems as they relate to standards\nMust possess good project management skills and initiative in taking on and completing projects\nMust possess advanced verbal and written communication skills\nMust be able to manage and prioritize multiple projects/objectives\nSalary Description\n$70-85,000","description_format":"text","description_chars":3885,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Manufacturing","Electronics Manufacturing","Contract 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