{"id":3258507,"url":"https://alion.io/job/boston-scientific-senior-quality-system-engineer-pal","title":"Senior Quality System Engineer (PAL)","company":{"id":1758528,"name":"Boston Scientific","domain":"bostonscientific.com","url":"https://alion.io/company/bostonscientific-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Eightfold","truth_index":{"grade":"B","score":82,"open_postings":74,"ghost_share":0.014,"stale_share":0.649,"repost_share":0.054,"time_to_fill_p50_days":32,"computed_at":"2026-10-30T05:48:23Z"}},"role":"DevOps","role_family":"DevOps","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["George Town, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":11000,"max_usd":30000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":3508},"experience_years_min":9,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"EU MDR","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-08-10T00:47:08Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-30T06:36:08Z","board_verified":true,"closed_at":null,"days_open":81,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":81},"description":"Key Responsibilities\nBatch Release Analytical QA support.\nImplementation of internal requirements and external laws, regulations, guidances and standards as applicable to Boston Scientific quality systems.\nHas expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO, cGMP and MDR).\nLead and support site External Inspections.\nPlan, coordinate and conduct scheduled audits to assess compliance with FDA, ISO, cGMP and MDR, other applicable standard requirements and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.\nIdentify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule.\nAttend global conference calls and meetings related to the internal audit process and etc.\nLead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.\nSupport the site corrective and preventive actions process.\nMaintain the BSC Penang CAPA process.\nDevelop and distribute CAPA metrics for facility management and the CAPA board. Work with CAPA phase owners to ensure timely completion of CAPAs.\nEducate functional areas on quality system requirements.\nParticipate cross functionally and across business units to standardize Boston Scientific Quality System policies and procedures.\nPotentially act as team member in supporting quality disciplines, decisions, and practices.\nMay on occasion be required to travel in order provide support the business or other sites in this area of responsibility.\nGather facility quality metrics for the management review presentation.\nCollect and analyze business/quality system process data from different parts of the company.\nIf applicable, to provide quality assurance support and direction to the analytical laboratory responsible for the testing and analytical batch release of all drug combination products and raw materials used at Penang Site. Responsible for ensuring that Raw Materials (specific to Active Pharmaceutical Ingredients, API), Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in BSC laboratories and at the contract laboratories. Provide support and guidance in the areas of cGMP, Compliance, Regulatory and laboratory investigation including Out Of Specification/Lab Investigation Report/Out Of Trend. Preparation and compilation of Annual Product Reviews on DES products. Schedule and complete laboratory assessments.\nRequirements\nDegree qualified in Science, Engineering, or a related discipline.\nMinimum 9 years of experience in quality background.\n\nExperience in the medical device industry is desirable.\nExperience in Non-Conforming Events and CAPA management.\nExperience in Internal Audit and External Audit activities.\nExperience in Management Review processes.\nStrong understanding of quality systems, regulatory compliance, and continuous improvement methodologies.\nAbility to work cross-functionally and drive quality system initiatives across the organization.\nRequired Skills\nKnowledge of ISO 13485.\nKnowledge of EU MDR.\nKnowledge of FDA Regulations.\nKnowledge in cGMP and Combination Device Regulations.\nLead Auditor qualification is desirable.\nInternal and external audit management.\nCAPA systems and quality system management.\nRegulatory compliance and quality assurance expertise.\nQuality metrics analysis and management review reporting.\nStrong analytical, problem-solving, and communication skills.\nCross-functional stakeholder management and collaboration.\nAbout Us\nAs a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.","description_format":"text","description_chars":3958,"description_truncated":false,"requirements":{"experience_years_min":9,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Cardiovascular Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-10-26T03:13:01Z"}],"visa":[],"liveness":{"score":12,"band":"cold","label":"Long shot","p_open":1,"p_active":0.416,"p_room":0.28,"age_days":81,"expected_fill_days":32,"reasons":["conf:3","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/boston-scientific-senior-quality-system-engineer-pal","json_url":"https://alion.io/job/boston-scientific-senior-quality-system-engineer-pal.json","meta":{"generated_at":"2026-10-30T08:13:12Z","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":11576,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":1758528},"rest":"https://alion.io/mcp/rest/get_company?id=1758528"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fboston-scientific-senior-quality-system-engineer-pal"},{"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%2Fboston-scientific-senior-quality-system-engineer-pal"},{"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%2Fboston-scientific-senior-quality-system-engineer-pal"},{"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/boston-scientific-senior-quality-system-engineer-pal\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fboston-scientific-senior-quality-system-engineer-pal"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3258507}},{"tool":"search_jobs","arguments":{"company":"bostonscientific.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3258507},"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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