Celestica is hiring a Design Assurance Manager to join the Global Engineering Services Quality team. You will provide technical support to maintain and improve the Quality Management System (QMS) for our design and engineering services organization. This role involves planning QA/RA projects, ensuring compliance to industry standards, and supporting global Design Centers across the medical device, aerospace & defense, industrial, and smart energy sectors.
What You'll Do
- Responsible for Document Control and Record Retention, ensuring all revisions comply with QMS requirements.
- Ensure standards used by Design Centers are current and provide summaries of updates.
- Facilitate CAPAs and NCRs assigned to Design Centers to ensure timely resolution and process adherence.
- Provide QMS coaching to global teams, ensuring Traceability matrices, Risk Management files, and project documents are correct.
- Support strategic development and continuous improvements within the QMS.
- Assist Sales and Marketing with customer quotes and proposals, ensuring Quality requirements are addressed.
- Support and facilitate improvements to Life Cycle and Design processes.
- Support Internal Audits as Lead Assessor or supporting auditor.
- Support 3rd Party Audits, including front and back room activities.
- Create slide decks for Management Review by gathering required inputs.
- Provide Training and Training governance on QMS procedures.
- Support Global Administration tasks, implementing SOPs/WIs for ISO 9001 and AS9100 Standards, and managing CAPA, Record Retention, Standards, and Training.
What We're Looking For
- 7+ years of experience in a regulated industry such as medical devices or aerospace.
- Skills in Design Analysis, Design Process, Design Reviews, Engineering Change Management, Quality Data & Statistical Analysis, Requirements Management, and Risk Assessment.
- Understanding of key Standards (ISO 13485:2016, ISO 14971:2019, AS9100D, ISO 9001:2015) and Regulations for Health Tech, Aerospace & Defense, and Commercial products.
- Knowledgeable about Documentation Control and Record Retention.
- Experienced in RCCA methodologies and facilitating CAPAs.
- Experience with 3rd Party Audits and FDA inspections as a Subject Matter Expert.
- Excellent understanding of the intent behind applicable Standards and Regulations.
- Highly capable facilitator of Continuous Improvement projects to develop more efficient processes.
- Knowledge of an electronic manufacturing environment, materials, manufacturing, and business processes.
- Ability to evaluate, prioritize, and problem-solve a variety of tasks to ensure timely and accurate completion.
- Ability to establish goals and coordinate diverse resources to meet quality and quantity metrics.
- Excellent verbal and written communication skills to interact with users, SMEs, and stakeholders.
- Ability to explain Regulatory and Standards concepts to both technical and non-technical audiences.
- Bachelor’s degree in Engineering or a related field. Equivalent practical experience may be considered.
Nice to Have
- ISO 13485:2016 Lead Assessor certification.
- Certified Quality Auditor (CQA).
- Master’s degree.
- Certified Quality Engineer (CQE).
Team & Environment
You will provide Global Quality oversight and support the Global Engineering Services Quality team.
Benefits & Compensation
- Compensation Range: $107,272 - $147,221 USD.
- A comprehensive benefits package is offered in addition to salary and target STI compensation.
Work Mode
This is a remote position for employees based in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
