{"id":1929518,"url":"https://alion.io/job/pci-sr-manager-quality-engineering-add","title":"Sr. Manager, Quality Engineering ADD","company":{"id":1987116,"name":"PCI","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Rockford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":108690,"max":136200,"currency":"USD","period":"year","gross":null,"usd_annual":136200},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-15T00:00:00Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-10-07T01:36:33Z","board_verified":true,"closed_at":null,"days_open":22,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":22},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\nWe are PCI.\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.\nEssential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.\nProvides strategy and leadership over the Quality Engineering (QE) teams at both Rockford Linden sites that are involved in supporting design transfer/control/assurance, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.\nDirect oversight and development of Quality Engineers responsible for Advanced Drug Delivery business segment assigning them to projects based on technical expertise and project priority\nLeads QE team to support New Product Introduction and tech transfer for product launches as well as supporting the sustaining commercialized products\nAccountable for overall management, reviewing, planning and administering of resource allocation and workload planning for the Quality Engineering staff.\nServe as subject matter expert (SME) and process owner for the Design Control and Risk Management procedures within the Quality Management System, including a risk management program aligned to ISO 14971\nOversee and approve PCI investigations including calibration OOS and laboratory or environmental monitoring product impact investigations.\nOversee and approve site supplier nonconformances and supplier related quality metrics\nProcess owner for Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R, test requirements and Test Method Transfer/Validation.\nTechnical evaluation of change controls including risk assessment / implementation of risk mitigation strategies.\nProvide high level guidance on complex design validation and verification (V&V) strategies, sampling plans and root cause investigations for design failure.\nOversee the feedback loop between Post-Market Surveillance (Complaints) and internal or external design assurance teams to trigger necessary design changes or CAPAs based on field reports.\nServe as the final Quality approver for major \"Stage Gate\" transitions, ensuring all design inputs, outputs, and transfer activities are complete and compliant.\nEnsure design assurance strategies align with evolving global standards, including ISO 13485 and FDA 21 CFR 820\nApply scientific statistical analysis techniques to proactively identify trends, identify root causes and implement actions to mitigate recurrence.\nOversees and provides input for statistical assessment of data to drive improvements.\nSupports and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction. \nParticipates as a member in various steering committees to guide and influence the company’s focus on new products, new customers, and strategic initiatives.\nPrepares reports to company management detailing the status of open projects that support the capacity, regulatory and quality improvement requirements of the plant.\nPresentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.\nEstablishes and ensures the Quality Engineering team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI’s. \nSupport the recruitment, coaching, and development of Quality Engineers to achieve excellence and efficiency when programs are scaled.\nCreates a “learning” culture that enables individuals to reach their maximum potential and builds the capability of the organization and generates energy, enthusiasm and commitment from others. \nEnsures budget development and the preparation of periodic projections of spending against budgets; and manages and controls departmental spending.\nPartners with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals\nParticipates in regulatory inspections, customer audits, visits and conference calls. \nSUPERVISORY RESPONSIBILITIES:\nLeads a group up to 10 direct reports across multiple sites. \nQualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nRequired:\nCollege or Trade Degree required (engineering degree or related scientific degree). Must have a minimum of 5+ years of experience in an FDA regulated industry with strong preference to medical device or combination products.\nDemonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.\nAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. \nFull Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.\nAnalytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.\nPreferred:\nPossesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.\nPrior experience in technical writing and utilizing root cause analysis tools is required.\nCritical thinking skills along with a strong collaborative approach is required.\nLean Six Sigma or other formal process improvement skillsets are highly desirable.\nTechnical knowledge and experience around Test Method validation, MSA, and Medical Devices processes is preferred.\nThe hiring rate for this position is $108,690-$136,200 plus eligibility for an annual 10% performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.\nAt PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.","description_format":"text","description_chars":7847,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Health insurance","Insurance coverage"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Clinical Trial Services (CRO)","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-05T21:20:39Z"}],"visa":[],"liveness":{"score":58,"band":"ok","label":"Likely open","p_open":1,"p_active":0.776,"p_room":0.75,"age_days":21,"expected_fill_days":30,"reasons":["conf:2","win:late","comp:brand"],"computed_at":"2026-10-06T05:45:30Z"},"pay":{"stated_usd_annual":136200,"is_top_pay":false},"html_url":"https://alion.io/job/pci-sr-manager-quality-engineering-add","json_url":"https://alion.io/job/pci-sr-manager-quality-engineering-add.json","meta":{"generated_at":"2026-10-07T01:49:08Z","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","counted_by":"address","units_charged":1,"used_today":2957,"day_limit":5000,"remaining_today":2043,"minute_limit":60,"resets_at":"2026-10-08T00:00:00Z"}},"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":1987116},"rest":"https://alion.io/mcp/rest/get_company?id=1987116"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpci-sr-manager-quality-engineering-add"},{"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%2Fpci-sr-manager-quality-engineering-add"},{"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%2Fpci-sr-manager-quality-engineering-add"},{"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/pci-sr-manager-quality-engineering-add\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-sr-manager-quality-engineering-add"}]}