58 applicants

Company

Original Job Post

Celestica · 3 days ago

Senior Lead Engineer, Design Quality

Maple Grove, MN

Full-time

Onsite

Senior Level

5+ years exp

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Responsibilities

Guide the quality assurance efforts in the design and development phase of new products in compliance with industry standards, regulations, guidance, and customer requirements

Supervising quality design activities and review of any deviations

Create/Review product risk management documentation (DFMEA, RMP, RMR, ...) in accordance with ISO 14971

Conduct RCA and structured problem solving (CAPA)

Support design reviews and transfers

Compliance gap analysis

Support design reviews and design transfers providing inputs on quality requirements

Attend and support internal and external Design Audits

Provide guidance and support to other engineers to ensure quality

Create and maintain quality plans

Support the creation of inspection criteria and risk mitigation strategies

Liaison to regulatory agencies and supports product certifications (FDA, FAA, third party test houses, and CE marking bodies)

Support QMS leader in maintaining QMS in compliance with 21 CFR820, ISO 13485, ISO 9001

Collaborate with suppliers to drive compliance and quality improvements

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality Management SystemsISO 9001ISO 13485FDA RegulationsMDR RegulationsRoHS RegulationsREACH RegulationsProduct DevelopmentMedical/HealthcareElectronic Product DevelopmentDesign ControlsDesign VerificationDesign ValidationCAPAs HandlingNon-ConformanceDeviationsComplaints HandlingProduct Evaluations ReportsNotifications to Competent AuthoritiesRisk AssessmentsFailure AnalysisRoot Cause InvestigationsFMEADOE8DStatistical AnalysisDesign Control DocumentationProduct LifecycleTransfer of ProductsVolume Manufacturing

Required

Strong knowledge of quality management systems, industry standards (such as ISO 9001, ISO 13485), and regulatory requirements (such as FDA, MDR, RoHS, REACH).

Proven experience on product development environment, specifically in the medical/healthcare arena. Solid understanding of electronic product development processes, including design controls, design verification, and validation.

Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)

Expertise in conducting risk assessments, failure analysis, and root cause investigations using tools and methodologies such as FMEA, DOE, and 8D.

Knowledge of statistical analysis tools

Experience in creating design control documentation during the whole lifecycle of the development process

Experience with previous transfer of products from design to volume manufacturing

Previous experience with PDM tools, product requirements and tracing

Ability to work independently, prioritize tasks, and manage multiple projects simultaneously

Bachelor degree minimum

Company

Celestica

Glassdoor

3.9

Celestica provides design, manufacturing, and supply chain solutions to a multitude of industries.

Founded in 1994

Toronto, Ontario, CAN

10,001+ employees

http://www.celestica.com

H1B Sponsorship

Celestica has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (4)

2022 (3)

2020 (3)