General Overview

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

Summary

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.

Responsibilities

• 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.

Knowledge/Skills/Competencies

• 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.

Physical Demands

• 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.

Typical Experience

• 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.

Typical Education

• 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.

Notes

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.