{"id":2600558,"url":"https://alion.io/job/smithnephew-engineer-2-quality-engineering","title":"Engineer 2, Quality Engineering","company":{"id":1768800,"name":"Smith+Nephew","domain":"smith-nephew.com","url":"https://alion.io/company/smith-nephew-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":81,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-15T05:46:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","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":10500,"max_usd":24000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":4825},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-15T07:58:31Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-16T01:51:20Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Engineer 2, Quality Engineering\nLife Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.\nThe Quality Engineer is responsible for supporting engineering projects and ensuring the quality, reliability, and continuous improvement of products and manufacturing processes. The role applies quality engineering principles, risk management, and problem-solving techniques throughout the product lifecycle to maintain compliance and drive operational excellence.\nThe position also reviews and approves Device History Records (DHR) for product shipment, investigates non-conformances and customer complaints, and supports root cause analysis and corrective actions. Working closely with cross-functional teams, the engineer helps improve process capability and product quality while supporting day-to-day manufacturing operations.\nIn addition, the role promotes compliance with Health, Safety, Environment (HSE), Sustainability, and Energy policies. This includes preventing workplace injuries, environmental incidents, and energy wastage, as well as reporting HSE incidents and contributing to continuous improvement initiatives.\nWhat will you be doing?\nBusiness Improvements\nSupports continuous improvement initiatives by applying quality tools such as Lean, Six Sigma, Kaizen, and PDCA to enhance product quality, process efficiency, and cost effectiveness. Also benchmarks best practices and develops quality engineering capabilities to support business growth.\nCompliance / Regulatory\nEnsures products and manufacturing processes comply with global regulatory requirements and quality standards. Supports audits, conducts production line assessments, and drives corrective and preventive actions to maintain compliance.\nNew Product / Process Introduction\nWorks closely with R&D and cross-functional teams to support new product introductions and design transfers, ensuring appropriate design controls, risk management, and product quality requirements are met.\nProduct Quality, Control & Disposition\nLeads material review activities and manages non-conformances, CAPAs, and customer complaints. Responsible for root cause investigations, quality metrics, defect management, and maintaining Device History Records (DHR) to ensure product quality and compliance.\nProduct / Process Qualification\nSupports process validation and qualification activities, including IQ, OQ, PQ, TMV, and software validation. Develops control plans, sampling plans, measurement systems, and process monitoring methods to ensure process capability and product quality.\nRisk Mitigation\nEvaluates process changes and quality risks to prevent non-compliance and product failures. Applies risk management principles to assess controls, implement mitigation measures, and ensure ongoing product safety and quality.\nStrategic\nDevelops and supports quality strategies for product, process, and test method validation. Participates in strategic initiatives and special projects assigned by management to support business objectives and continuous improvement efforts.\nWhat will you need to be successful?\nThe Quality Engineer is responsible for leading sustaining quality activities and supporting new product transfers by ensuring manufacturing processes are capable, compliant, and deliver consistent product quality. The role focuses on process validation, risk management, regulatory compliance, and continuous improvement while supporting production and meeting customer quality expectations.\nThe ideal candidate should hold a Bachelor's degree in Engineering or a related technical field, with experience in manufacturing and regulated environments such as FDA and European standards. Strong knowledge of Lean, Six Sigma, statistics, risk management, process validation, and GMP/ISO requirements is essential, along with proven problem-solving, project leadership, data analysis, and cross-functional collaboration skills.\nYou.Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. \nInclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/ \nWork/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day \nYour Wellbeing: Medical, Dental, Vision, Health Savings Account , Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program \nFlexibility: Hybrid Work Model (For most professional roles) \nTraining: Hands-On, Team-Customized, Mentorship\nStay connected by joining our Talent Community.\nWe're more than just a company - we'rea community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.\nCheck us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.\nExplore our website and learn more about our mission, our team, and the opportunities we offer.","description_format":"text","description_chars":5046,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Hybrid work","Parental leave"],"hiring_locations":[{"name":"Malaysia","iso":"MY","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-10-15T07:58:31Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":24,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-10-16T04:06:55Z"},"pay":null,"html_url":"https://alion.io/job/smithnephew-engineer-2-quality-engineering","json_url":"https://alion.io/job/smithnephew-engineer-2-quality-engineering.json","meta":{"generated_at":"2026-10-16T04:06:55Z","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":740,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"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":1768800},"rest":"https://alion.io/mcp/rest/get_company?id=1768800"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsmithnephew-engineer-2-quality-engineering"},{"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%2Fsmithnephew-engineer-2-quality-engineering"},{"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%2Fsmithnephew-engineer-2-quality-engineering"},{"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/smithnephew-engineer-2-quality-engineering\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmithnephew-engineer-2-quality-engineering"}]}