{"id":1701642,"url":"https://alion.io/job/biomerics-senior-quality-engineer","title":"Senior 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":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Salt Lake City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":64000,"max_usd":121000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5037},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-01T14:31:10Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-12T22:43:26Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"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\nThe Senior Quality Engineer will play an important role within the Biomerics Extrusion, Metals, and Plastics team, providing Quality Engineering leadership in developing, establishing, and maintaining Quality Engineering methodologies, systems, and practices, which meet internal, customer, and regulatory requirements.\nResponsibilities\nParticipate in Product Development teams, providing Quality input and support \nDevelop and implement Control Plans, Master Validation Plans, and Inspection Procedures \nDevelop validation strategies, ensuring all applicable requirements are met from planning, protocol definition, leading execution of protocols, analyzing and reporting results, and completing report and gaining necessary approvals to close \nLeading the development and results analysis of validation plans (IQ/OQ/PQ), Test Method Validation (TMV), Gage R&R, and test protocols to qualify and validate existing product designs, processes, and equipment \nDetermine and recommend sampling plans, equipment requirements, measurement techniques, and training requirements that will ensure specific quality levels \nSupport new product introductions and design changes \nSupport Manufacturing Engineering in the creation, release, and maintenance of DHR, Bill of Materials, and manufacturing specifications \nReview and approve product documentation \nLeads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization \nEnsure risk management processes are followed and documented \nEnsure compliance to Biomerics quality standards, policies, and procedures \nSupport external customer and regulatory agency audits \nMaintain consistent dialogue with customers and teammates to ensure clear communication and expectations \nLead investigations for nonconformances and customer complaints \nUtilize problem solving tools to analyze and identify root causes and implement corrective actions \nIdentify opportunities for process improvement and implement solutions \nMonitor quality performance metrics and trends \nProvide leadership and mentoring to other Quality team members \nPromote a culture of quality and foster a culture of compliance and continuous improvement \nRequirements\nBachelor's degree in Engineering, Quality, or a related field or equivalent experience \nMinimum of 5-7 years of experience in Quality Engineering within a medical device manufacturing environment \nWorking knowledge of process development and validation \nStrong knowledge of Quality Systems and regulations (e.g., FDA QSRs, ISO 13485, ISO 14971). \nExperience with root cause analysis, CAPA, and risk management. \nFamiliarity with statistical tools and methods. \nKnowledge of medical device design and manufacturing processes. \nASQ certifications (e.g., CQE, CQA) are preferred \nStrong problem-solving and analytical skills \nExcellent communication and interpersonal skills \nProficiency in Microsoft Office and Minitab \nAbility to work independently and as part of a team \nStrong organizational and project management skills \nSalary Description\n85-100k","description_format":"text","description_chars":4394,"description_truncated":false,"requirements":{"experience_years_min":5,"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 Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-02T13:37:39Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 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