{"id":356656,"url":"https://alion.io/job/insulet-director-quality-operations","title":"Director, Quality Operations","company":{"id":5958,"name":"Insulet","domain":"insulet.com","url":"https://alion.io/company/insulet","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":19,"ghost_share":0,"stale_share":0.316,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-10-01T05:45:00Z"}},"role":"Operations","role_family":"Operations","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":26000,"max_usd":56000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1115},"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Power BI","optional":false}],"status":"live","first_seen_at":"2026-08-27T00:00:00Z","employer_posted_date":"2026-08-27","last_verified_at":"2026-10-01T04:33:08Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":35},"description":"Job Summary\nThe Director, Quality Operations will manage site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable country-specific regulatory requirements. This position will also perform role of site Quality System Deputy Management Representative with responsibility for ensuring processes needed for the Quality Management System (QMS) are documented, reporting to top management on the effectiveness of the QMS and any need for improvement, and ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization.\n\nResponsibilities\nLeads a team of Quality Engineers (QE), Quality Control (QC), and Quality Assurance (QA) associates, ensuring strong performance, professional development, and effective collaboration with key stakeholders. Responsible for all aspects of Factory Quality, from Incoming Inspection through Final Product Release.\nEstablishes, maintains, and promotes strategies to achieve quality objectives and ensure compliance with applicable quality and regulatory requirements.\nEnsures timely and accurate evaluations and investigations and implements appropriate actions to maintain product safety and effectiveness based on investigation outcomes.\nManages and ensures timely follow-up of activities related to internal and external Quality Management System (QMS) audits.\nEstablishes, maintains, and promotes a culture of quality, compliance, and customer focus throughout the organization.\nEnsures the effectiveness of the site's Corrective and Preventive Action (CAPA) system.\nEnsures the effectiveness of the site's Quality Planning process.\nEstablishes and maintains a robust employee training program.\nSupports the establishment and maintenance of a robust Environmental Monitoring Program.\nEnsures that products are not released for distribution until all Device Master Record (DMR) requirements have been met.\nResponsible for establishing and maintaining effective and efficient statistically based Quality Control processes, including incoming, in-process, and finished product inspection and release.\nEnsures company operations comply with all applicable laws, regulations, standards, good business practices, and documented company procedures, including all occupational health, safety, and environmental regulations applicable to the site.\nPartners with key global stakeholders to drive harmonization, standardization, and continuous improvement initiatives.\nEngages, promotes, and participates in Environmental, Health, and Safety (EHS) initiatives, with a focus on continuous improvement.\nKey Decision Rights\nServes as a member of the IMY Plant Leadership Team (PLT) and partners with key site and global stakeholders.\nServes on the IMY Material Review Board (MRB) Committee.\nActs as the IMY Management Representative and serves as a key stakeholder during internal, external, and regulatory audits.\nServes on the IMY CAPA Change Review Board (CRB) Committee.\nOwns and manages the budget for all IMY Quality Assurance Operations.\nRequired Leadership / Interpersonal Skills & Behaviours\nCollaborates effectively and drives continuous improvement across functions and global teams.\nIdentifies and leads continuous improvement opportunities.\nAligns team objectives with broader organizational goals and objectives and tracks progress against established targets.\nLeads, develops, and mentors a team of quality professionals in a fast-paced environment.\nRequired Skills and Competencies\nDemonstrated ability to make risk-based decisions in collaboration with others and in accordance with established Quality Management System (QMS) processes.\nExcellent communication skills and the ability to work collaboratively with cross-functional teams.\nGlobal mindset with the ability to work effectively in a matrixed organization.\nBroad quality experience, including Incoming Quality, Quality Assurance, Quality Control, Quality Engineering, and Quality Systems.\nStrong analytical skills with the ability to interpret complex data and drive effective decision-making.\nEducation and Experience\nBachelor’s degree in Science, Engineering, or a related discipline is required.\nA minimum of 12 years of experience in Medical Device Quality Operations, including at least 10 years in a Quality Manager or equivalent leadership role. Experience in high-volume electromechanical device manufacturing is preferred.\nBroad knowledge of manufacturing, product development, engineering processes, equipment, methodologies, and techniques.\nSignificant knowledge and experience in designing, implementing, and maintaining Quality Management Systems and manufacturing processes that comply with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.\nIntermediate to advanced proficiency in Microsoft Word, Excel, Data Analytics tools, Power BI, or equivalent software.\n Additional Information\nThis position is based on-site at the Insulet Malaysia (IMY) manufacturing facility.\nTravel is estimated at approximately 10% and may vary based on business needs.\n Note: This position requires on-site work and is not eligible for remote or hybrid work arrangements.\nInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.\nWe are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!","description_format":"text","description_chars":5791,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":10,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Hybrid work","Professional development"],"hiring_locations":[{"name":"Malaysia","iso":"MY","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-09-05T19:19:42Z"}],"liveness":{"score":37,"band":"fade","label":"Fading","p_open":1,"p_active":0.666,"p_room":0.55,"age_days":35,"expected_fill_days":26,"reasons":["conf:1","velocity","win:tail","comp:brand"],"computed_at":"2026-10-01T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/insulet-director-quality-operations","json_url":"https://alion.io/job/insulet-director-quality-operations.json","meta":{"generated_at":"2026-10-01T10:10:06Z","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":1235,"day_limit":5000,"remaining_today":3765,"minute_limit":60,"resets_at":"2026-10-02T00:00:00Z"}}}