Senior Design Quality Lead Engineer

Celestica; Maple Grove (MN); On-site; USD 95,000 - 126,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Short and Long-Term Disability

Life Insurance

401k with company match

Job summary

Celestica is seeking a Lead Engineer, Design Quality to advance quality assurance during product design and development across medical, aerospace/defense, industrial, and smart energy sectors. You will guide QMS activities, ensure compliance with standards, and support FDA/CE submissions while mentoring engineering teams worldwide.

Your role entails leading design controls per CFR/ISO standards, coordinating audits, and shaping risk management artifacts to enable successful product transfers to

Qualifications

• Bachelor's degree or Technology equivalent in relevant field (Mechanical/Electrical/Software design)
• CQA = Certified Quality Auditor is a plus
• Four to six years of relevant experience
• Knowledge of ISO13485, ISO9001, AS9100, 21 CFR 820 is beneficial
• Strong communication and leadership skills

Responsibilities

• Develop and modify Quality Management Systems and facilitate improvements.
• Participate in design reviews and design transfers focusing on quality requirements.
• Develop Design Controls per 21 CFR 820, ISO 13485, AS9100 and ISO 9001.
• Lead internal and external Design Audits and address findings.
• Provide guidance to engineers and promote a culture of quality.
• Ensure engineering deliverables comply with relevant standards.
• Review supplier quality compliance and support regulatory submissions (FDA, EU MDR).
• Create, update and review risk management documents (Hazard analysis, DFMEA, RMR, RMP).
• Manage complex engineering projects with cross-functional teams and budgets.

Job description

Celestica is seeking a Lead Engineer, Design Quality to advance quality assurance during product design and development across medical, aerospace/defense, industrial, and smart energy sectors. You will guide QMS activities, ensure compliance with standards, and support FDA/CE submissions while mentoring engineering teams worldwide.

Your role entails leading design controls per CFR/ISO standards, coordinating audits, and shaping risk management artifacts to enable successful product transfers to