{"id":1163469,"url":"https://alion.io/job/medline-sr-engineer-quality-3","title":"Sr Engineer Quality","company":{"id":7482,"name":"Medline","domain":"medline.com","url":"https://alion.io/company/medline","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":48,"ghost_share":0,"stale_share":0.771,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-09-25T05:45:01Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Northfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":101000,"max":152000,"currency":"USD","period":"year","gross":null,"usd_annual":152000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Excel","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-09-23T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-25T06:39:28Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Summary\nUnder minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.Job Description\nMAJOR RESPONSIBILITIES:\nManage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.\nDesign complex experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.\nDesign and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.\nDirect and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.\nProvide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required. Coordinate product testing with internal and external laboratories as required.\nEnsure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.\nLead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).\nMay train and coach team members and Medline employees on appropriate processes and best practices.\nAct as Quality lead in the absence of Quality Management.\nMINIMUM JOB REQUIREMENTS:\nEducation:\nTypically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.\nCertification / Licensure:\nNone\nWork Experience:\nAt least 4 years of experience in Quality or Engineering.\nExperience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards).\nKnowledge / Skills / Abilities:\nExperience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation is necessary.\nExperience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.\nExperience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations.\nExperience leading a team to accomplish cross-functional goals.\nExperience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook).\nAdvanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting)\nPosition requires up to 15% travel\nPREFERRED JOB REQUIREMENTS:\nEducation:\nNone\nCertification / Licensure:\nNone\nWork Experience:\nAt least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.\nKnowledge / Skills / Abilities:\nKnowledge of advanced Six Sigma/Lean concepts.\nMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.\nThe anticipated salary range for this position:\n$101,000.00 - $152,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.\nOur benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.\nWe’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.\nMedline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.","description_format":"text","description_chars":5598,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Health insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Supplies & Consumables","Wound Care","Medical Equipment Distribution"],"lifecycle":[{"event":"open","at":"2026-09-24T01:04:56Z"}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":26,"reasons":["conf:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-09-25T05:45:01Z"},"pay":{"stated_usd_annual":152000,"is_top_pay":false},"html_url":"https://alion.io/job/medline-sr-engineer-quality-3","json_url":"https://alion.io/job/medline-sr-engineer-quality-3.json","meta":{"generated_at":"2026-09-26T02:10:50Z","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":2205,"day_limit":5000,"remaining_today":2795,"minute_limit":60,"resets_at":"2026-09-27T00:00:00Z"}}}