Req ID: 118203
Remote Position: Yes
State/Province: New Hampshire
Functional Area: Operations (OPS)
Career Stream: Quality (QUA)
Role: Manager 2 (MG2)
Job Title: Quality Manager 2
Job Code: MG2-OPS-QUA
Job Level: Level 10
Direct/Indirect Indicator: Indirect
We are currently seeking a Global Project Manager Quality in our Health Tech division to join our global Quality team to lead our expansion into the Health Tech market, with impeccable product and process quality. The successful candidate will have significant experience in FDA and MDSAP certification processes and will lead the efforts of multiple support organizations globally to ensure successful engagements with Celestica’s customers, suppliers and other partners in the Health Tech arena.
This is a Remote position that can be home based or at an existing Celestica site anywhere in the US with good access to an airport.
- Lead and/or support implementation and deployment of Celestica’s Health Tech Global Quality Strategies [i.e. Global QMS, FDA, MDSAP, EU MDR/IVDR, Best Practices, Quality Culture, Quality Improvements (Sterilization, Supplier)] by assessing gaps and developing short and long-term plans, working hand-in-hand with Site management, and implementing actions.
- Monitor Global QMS Health Tech metrics in support of business priorities and lead improvements of the quality culture and performance across Health Tech sites.
- Improve and monitor Global QMS Health Tech sites for compliance as well as necessary tools and system applications.
- Drive Quality “Audit Ready” Culture with the Health Tech sites to ensure an effective system of internal audits is in place and development of internal and supplier auditors across the network as well as supporting external audits (i.e. Notified Bodies, Suppliers).
- Drive supplier quality improvements with the Health Tech sites and functional groups to ensure an effective system of supplier qualifications and monitoring is in place.
- Conduct audits of Health Tech sites and/or suppliers as required to monitor compliance and support external audits execution.
- Coordinate periodic Quality Management Reviews and training with Health Tech sites and advise management of potential risks along with mitigation plans and recommendations.
- Support the Health Tech sites with quality guidance to document quality issues as well as the actions taken to effectively resolve these issues through 8D methodology to comply with CAPA process.
- Conduct Quality training to develop and train Health Tech site personnel on QMS topics as required, especially Audits, CAPA, Risk, Validation, and Supplier topics.
- Provide quality program management leadership and support for special projects and/or initiatives as required, as well as guidance and leadership to various Quality communities and other internal teams.
- Strong knowledge of Quality Management System’s regulations and standards for medical devices in Health-Tech (e.g. 21 CFR 820, ISO13485, ISO 14971, MDSAP, EU MDR/IVDR).
- Outstanding relationship management and interpersonal skills with ability to communicate, motivate, lead, and manage internal and external customers.
- Strong Microsoft Office skills with ability to conduct complex data analysis, detailed status charts, reports and presentations.
- Thorough understanding of validation principles and testing procedures with solid analytical, statistical and problem solving skills.
- Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion of tight timelines.
- Excellent knowledge and understanding of medical device’s design, manufacturing, quality, and business processes environment.
- 25% travel requirements
- Duties of this position are performed in a normal office environment.
- Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.
- Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
- Occasional travel may be required.
- 7-10 years with leadership experience in quality management and/or related functions, including experience in Manufacturing Quality, Design Quality, Validation, Quality Assurance and Quality Systems.
- A minimum of 5 years’ experience conducting quality audits for both internal and external stakeholders (e.g. FDA, Notified Bodies, Customers).
- In-depth knowledge of quality management systems and demonstrated experience in managing compliance in various countries.
- A minimum of 5 years’ experience in Health-Tech business.
- Global and multi-site leadership experience.
- Prior experience in driving cultural change initiatives in medium-to-large organization to drive Quality awareness.
- Bachelor’s degree in Engineering or Science related field or consideration of an equivalent combination of education and experience.
- RAC(US), CQA, ASQ, or ISO/RABSQA Auditor Certification an asset, but not required.
This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.
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.
Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40 locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.