{"id":1187441,"url":"https://alion.io/job/getinge-quality-specialist-i-inspection-coordinator","title":"Quality Specialist I (Inspection Coordinator)","company":{"id":719311,"name":"Getinge","domain":"getinge.com","url":"https://alion.io/company/getinge-2","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Administrative","role_family":"Administrative","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Fraser, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":75000,"max":94000,"currency":"USD","period":"year","gross":null,"usd_annual":94000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-14T00:00:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-09-25T03:28:17Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"With a passion for life\nJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.\nAre you looking for an inspiring career? You just found it.\n\nJob Overview\nThe primary purpose of this position is the Quality Specialist (Inspection) will provide quality support of day-to-day Quality operations of all elements related to quality inspection within the Healthmark Quality Management System (QMS).\n\nJob Responsibilities and Essential Duties:\nPerform all Quality functions in compliance with Quality Management System (QMS) according to 21CFR820, ISO 9001:2015, and ISO 13485:2016.\nConduct internal audits of facility to ensure compliance with regulatory requirements under the guidance of the Head of Quality Systems and Compliance.\nTrain new Quality employees and facilitate the on-boarding process. \nParticipate in third party audits (FDA, ISO, other notified bodies) of the Quality System and assist with providing responses to any observations made during those audits.\nAssist management with ongoing Quality improvement initiatives. Track or trend Quality System metrics.\nDetermine source of Quality problems, make recommendations for improvements, and assist with corrective and preventative actions.\nLead inspection establishments. Lead establishment of inspections within the ERP tool from approved inspection plans.\nAssists in quality documentation as related to New Equipment Request and changes\nMay assist in equipment qualification and validation\nAssist in monthly presentation and defect trending of product quality performance to management as related to inspection\nMay be required to perform other duties as assigned or as needed.\nRequired Knowledge, Skills and Abilities: \nCommunicating both orally and written with members of the organization, as well as external parties relating to Quality issues. \nOrganizing and prioritizing daily duties.\nMust be a team player and able to work well with teams representing all areas of the organization.\nProblem solving and decision making - identifies and solves problem(s), acts decisively, and shows good judgement.\nMaintain appropriate focus on short-term and long-term goals.\nMinimum Requirements:\nRequires a Bachelor’s degree with 3+ years of experience in Quality within FDA regulated environment. \nOR\nRequires a Master’s degree in Quality or any closely related field with 1+ year of experience in Quality within FDA regulated environment.\nOR\nAn equivalent combination of education and experience sufficient to successfully perform the essential duties. \nStrong knowledge of medical device regulatory requirements, including FDA 21CFR 820, ISO 9001:2015, ISO 13485:2016, etc. Medical device experience highly preferred.\nAudit training preferred. \nFundamentals of technical writing.\nStay abreast of current applicable Quality and Regulatory standards, guidance documents and industry working groups.\nEnvironmental/Safety/Physical Work Conditions: \nStanding and or sitting for long periods of time.\nThe physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\n\nThe salary range for this position is between $75,000-$94,000/annually depending on experience and 8% STIP for 2027\nAbout us\nWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.\nBenefits at Getinge:\nAt Getinge, we offer a comprehensive benefits package, which includes:\nHealth, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement\nGetinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.","description_format":"text","description_chars":4969,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiovascular Devices","Hospital Equipment & Furniture","Sterilization & Infection Control"],"lifecycle":[{"event":"open","at":"2026-09-24T15:08:33Z"}],"liveness":{"score":51,"band":"ok","label":"Likely open","p_open":1,"p_active":0.683,"p_room":0.75,"age_days":11,"expected_fill_days":12,"reasons":["conf:2","win:late","comp:junior,brand"],"computed_at":"2026-09-25T05:45:01Z"},"pay":{"stated_usd_annual":94000,"is_top_pay":true},"html_url":"https://alion.io/job/getinge-quality-specialist-i-inspection-coordinator","json_url":"https://alion.io/job/getinge-quality-specialist-i-inspection-coordinator.json","meta":{"generated_at":"2026-09-26T02:18:34Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":2336,"day_limit":5000,"remaining_today":2664,"minute_limit":60,"resets_at":"2026-09-27T00:00:00Z"}}}