Job Title Manager, Operations Quality 2 Job Summary We are seeking a highly technical, strategic Quality Technical Services (QTS) Hub Manager (Band 10) to lead our newly centralized technical quality command. This critical leadership role uncouples deep technical engineering investigations from day‑to‑day administrative burdens. You will directly oversee high‑risk, high‑impact manufacturing and regulatory support pillars, shifting the site toward a proactive system health model. Physical Demands Must be able to access and move safely within cleanroom environments, microbiology laboratories, and manufacturing production lines. Standard office environment tasks, including extended periods of sitting, computer line‑of‑sight operations, and collaborative cross‑functional reviews. Knowledge / Skills / Competencies Mandatory Qualifications & Background Regulatory Compliance: Proven, deep hands‑on expertise operating within ISO 13485 certified and FDA‑registered facilities. Domain Competencies: Demonstrated on‑the‑job experience across critical quality pillars including: Sterilization Assurance, Environmental Control/Microbiology, New Product Introduction (NPI), Project Management, Quality Management Systems (QMS), Continuous Improvement (CI), CAPA Management, Advanced Process Controls, Internal/External Regulatory Audits, Customer Complaints Management, Quality Core Tools (PFMEA, SPC, MSA, PPAP), and strategic Personnel Development. The Right Candidate For This Position Holds Advanced knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 11135 / 11137 (Sterilization standards). Proven track record of managing automated product release projects, validating production equipment (IQ/OQ/PQ), and optimizing quality inspection parameters (Smart Inspection). Strong leadership capability with a demonstrated history of expanding cross‑functional team exposure and accelerating the development/coaching of personnel. Excellent technical writing skills for standardizing technical reports, addressing regulatory inquiries, and managing technical risk assessments (PFMEAs). Sharp analytical, communication, and presentation skills to effectively interface during high‑pressure regulatory audits. Typical Experience Experience: 10+ years of recent, progressive professional experience in Quality Engineering or Quality Operations, with a minimum of 5 years in a direct supervisory or managerial capacity managing technical contributors/engineers within the Medical Device field according to the responsibilities listed below. Centralized Technical Authority: Provide strategic leadership and technical governance over Sterilization Assurance, Microbiology/Laboratory Services, and Technical Systems Engineering. Proactive System Health: Deploy advanced Quality Engineering expertise to focus on automated release projects, standardized technical reporting, and system health metrics to aggressively reduce human error. Risk De‑risking: Lead engineering efforts to drive proactive Process Failure Mode and Effects Analysis (PFMEA) updates and provide immediate technical governance during site‑critical manufacturing events. Efficiency & Optimization: Champion "Smart Inspection" initiatives to increase operational efficiency across manufacturing lines without adding headcount. Typical Education Bachelor of Science (B.S.) degree in Engineering (Biomedical, Chemical, Mechanical, or Electronics) or a hard scientific discipline (Microbiology, Biochemistry, or related Life Sciences field) or demonstrated equivalent experience. Equal Employment Opportunity Statement Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them. #J-18808-Ljbffr