{"id":1881722,"url":"https://alion.io/job/sanner-group-quality-operations-specialist","title":"Quality Operations Specialist","company":{"id":3865995,"name":"Sanner Group","domain":"sanner-group.com","url":"https://alion.io/company/sanner-group","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Operations","role_family":"Operations","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Pittsboro, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-23T16:24:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-11-02T13:41:58Z","board_verified":true,"closed_at":null,"days_open":39,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":39},"description":"Do you have a passion for helping bring innovative medical devices and drug delivery products to market that improve patient lives? Gilero, a Sanner Group company, is seeking an experienced Quality Operations Specialist to support our Pittsboro, NC facility. You will be responsible for Quality Operations to support transition between development and commercial manufacturing activities.\nDuties:\nLiaise between product development and manufacturing project teams to ensure compliant design transfer\nCoordinate, assemble, and route documentation per quality system lifecycle requirements\nPerform incoming inspection/testing and release of accepted materials\nPerform pilot builds in cooperation with operations and design transfer teams\nConduct labeling verification in accordance with product requirements\nPerform in-process testing and QA inspections per product requirements\nCoordinate environmental monitoring, including particle counts and temperature/humidity/pressure measurements\nCoordinate cleaning of controlled environment areas per internal procedures\nManage third-party environmental testing and approve results\nSupport sterilization coordination\nReview batch records for accuracy and completeness. Collaborate with manufacturing and development teams to resolve any batch documentation-related errors or gaps\nSupport quality event initiation and investigation for nonconformances, CAPA, change control and complaints.\nSupport continuous improvement projects and audits\nSkills/Qualifications:\nBachelor’s degree or equivalent combination of education and experience.\n0 - 5 years in regulated manufacturing environment\nExperience with FDA 820 CFRs/ISO 13485/cGMP quality management system requirements and medical devices/combination product development\nBasic experience with coordination of GMP compliant Documents, Records, and Training\nStrong written and verbal communication skills\nPreferred:\n5+ years in medical device manufacturing\nExperience with quality operations, design transfer and GxP concepts\nExperience with GMP manufacturing operations and process development\nASQ or related certification\nPersonal Attributes:\nMeets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity\nProductive in a fast-paced, entrepreneurial environment.\nCommits to excellence and quality service to external and internal customers.\nAdheres to established policies and procedures, while contributing to continuous improvements.\nEligibility To Work\nApplicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.\nGilero does not offer sponsorship for employment authorizations (work visas).\nWe are an E-Verify employer and confirm work authorization for all new hires.\nWhy work at Gilero?\n Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our teams continue to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Durham, Greensboro, and Pittsboro.\nYou will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.\nWhat We Offer\nCompetitive base salary plus incentive compensation\nAnnual performance bonus\nMedical, dental, and vision insurance (multiple BCBS medical plan options)\nCompany paid life insurance, short- and long-term disability coverage\n401(k) with company match beginning the first month after you start and immediate vesting in company match \nPaid parental leave\nPaid Time Off and company holidays\nLinkedIn Learning for professional development\nCareer growth opportunities within Gilero and the global Sanner Group","description_format":"text","description_chars":4189,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Growth opportunities","Life insurance","Parental leave","Professional development","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-05T00:10:37Z"}],"visa":[],"liveness":{"score":26,"band":"fade","label":"Fading","p_open":1,"p_active":0.579,"p_room":0.45,"age_days":39,"expected_fill_days":24,"reasons":["conf:1","win:tail"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/sanner-group-quality-operations-specialist","json_url":"https://alion.io/job/sanner-group-quality-operations-specialist.json","meta":{"generated_at":"2026-11-02T16:14:17Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":22656,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3865995},"rest":"https://alion.io/mcp/rest/get_company?id=3865995"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsanner-group-quality-operations-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsanner-group-quality-operations-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsanner-group-quality-operations-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/sanner-group-quality-operations-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsanner-group-quality-operations-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1881722}},{"tool":"search_jobs","arguments":{"company":"sanner-group.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1881722},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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