{"id":4034749,"url":"https://alion.io/job/integer-post-market-surveillance-engineer-ii-2","title":"Post Market Surveillance Engineer II","company":{"id":6616,"name":"Integer","domain":"integer.net","url":"https://alion.io/company/integer","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":76,"open_postings":33,"ghost_share":0,"stale_share":0.97,"repost_share":0,"time_to_fill_p50_days":23,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Plymouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-10T19:48:13Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-11T01:38:42Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.\nAt Integer, our values are embedded in everything we do.\nCustomer \nWe focus on our customers’ success\nInnovation \nWe create better solutions\nCollaboration \nWe create success together\nInclusion \nWe always interact with others respectfully\nCandor \nWe are open and honest with one another\nIntegrity \nWe do the right things and do things right\n\nWhat you’lldo in this role:\nThe primary purpose of this job is toexecute and support the Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes for Integer under the direction, instruction and guidance from more experienced associates and managers in your organization. This position will be responsible forexecuting and providing support in the analysis, evaluation and product investigation of complaints received from externalcustomersin a timely mannerto comply withFDA 21 CFR(QSR)requirements and requirements of other regulatory bodies andcountrieswith some instruction and guidance from more experienced associates and managers.\n\nYou adhereto Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.\n\nPost Market Complaint Handling Activities:\nYou will be responsible foraccurately capturing and documenting allcomplaints in the complaint handling database according to internal policies and procedures.\n\nYou will be responsible forsending complaint acknowledgements to customers.\n\nYou will be responsible fortracking customer return products.\n\nYou will be responsible forperformingcomplaint investigation activities with cross functional team members.\n\nYou will be responsible forreviewing device history recordsfor nonconformities related to the alleged complaint.\n\nYou will interface withinternal and external customers to gather additionalinformation requiredfor complaint investigations and preparecustomer communication,complaint investigation reportsand Customer Facing Reports,as applicable.\n\nYou will executedata collection, root cause investigationsand resolution in support of a thorough complaint investigation related to product quality and patient safety.\n\nYou will play an active role in ensuringtimelyclosure of complaint investigations to comply withrequirements of FDA and other regulatory bodies and countries.\n\nYou may be requiredto handle, decontaminate,and analyze products used in the field by hospitals/end users per internal procedures and safety requirements, which will require you to have relevant vaccinations.\n\nYou will be responsible forperforming risk assessments for products that are Integer owned designs.\n\nYou will be responsible forperforming CAPA assessments and supportingCAPA investigations.\n\nYou will be responsible forassessing Adverse Event Reportability decisions in accordance withUS and International regulations.\n\nYou will be responsible for assisting in the completion of applicable forms for submission of reportable complaints to applicable agencies.\n\nYou will assistin gathering complaintand ship data to support Post Market Trending,PMSRs, and PSUR’s.\n\nYou are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support in your development as a Post Market Surveillance EngineerII.\n\nAudit Support:\nYou will be responsible forsupporting internal and external audits. Provide support for external regulatory inspections and customer audits. Support the timelyresponse and closure of audit observations and findings.\n\nQuality System Responsibilities:\nYou will performwork onprojects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.\n\nYou are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an Associate Product Surveillance Engineer.\n\nYou embed Quality within the Regulatorydiscipline - “I own Quality.” You are astandard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitatingand/or contributing to corrective and preventive actions, and contributing to the successful\n\nattainment of our quality KPI’s and journey to 5 Sigma.\nYou may performother duties as needed and as directedby your line of supervision.\n\nManufacturing ExcellenceImperatives:\nProvide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies\n\nParticipation or Leadership inSite Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives\n\nProvide leadership as requiredfor QA RA weekly and monthly metrics, supporting the walk to 5 sigma.\n\nLeadership of Sustained Change ensuring customer change notifications are initiatedand completed, as necessary, and supporting continuous improvement activities as required.\n\nSupport the standardisation of workplace organization & visualcontrols (5S), Manufacturing Standard Work, and robust training & certificationprograms where applicable.\n\nAssociate Engagement promoted through the adoption of standardized problem solving. methodologies, behaviour-based safety programs, and improvement idea and suggestion systems.\n\nSystems & Process Optimization through adoption of principles of builtin quality,\n\nHow you will be measured:\nThe specific measures listed below may be subject to change and are not intended to be an all-inclusive list.\nSafety is our highest priority; you will be an active supporter of the Integer Environmental,Health & Safety programs.\n\nAdhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation.\n\nYou will have defined Goals and Objectives specifying key projects and expected milestones to achieve.\n\nAchievement of site quality KPI’s\n\nInnovation and ideation are critical aspects of your role,and you will be expected to generate continuous improvement suggestions and support the implementation of them.\n\nWhat sets you apart:\nMinimum Education and Experience:\nYou have earned, as a minimum, abachelor’sdegree and have at least 1 yearof relevant experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years’ relevant experience(medical device or other regulated industry experience preferred).\n\nSpecialized Knowledge:\nWhile you will have occasionalsupport and guidance from more experienced Post Market Surveillance professionals, supervisorsor managers, you will demonstratethe ability to work independently as well as collaboratively withother associates andcross functional teams.\n\nSpecialized Skills:\nYou demonstratea solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.\n\nYou demonstratecompetencies in bothwritten and oral communications.\n\nYou are highly organized and able to work and track multiple projects and complaints simultaneously.\n\nYou possessintermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, Excel, Word, etc.)\n\nYou possessapositive, can-do attitude with an underlying belief that failure is not an option.\n\nSalary range $70,950 - $104,060\n#IND1\n\nOur total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.\n\nU.S. Applicants: Equal Opportunity Employer. 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