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Resolution Medical · 4 hours ago

Design Assurance Quality Engineer II - Medical Device

Fridley, MN

Full-time

Onsite

Mid, Senior Level

$85K/yr - $100K/yr

4+ years exp

Resolution Medical LLC is a company focused on medical device product development. The Design Assurance Engineer will support product development from concept through commercialization, ensuring compliance with design control deliverables, risk management activities, and maintaining the highest quality standards.

Health CareMedical Device

Culture & Values

H1B Sponsor Likely

Responsibilities

Adheres to Resolution Medical’s Core Beliefs and all safety and quality requirements

Apply sound, systematic problem-solving methodologies to resolve quality issues

Act as an effective team member in supporting quality disciplines, decisions, and practices

Monitor field performance of recently launched and established medical devices against risk assessments

Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization

Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements

Partner cross-functionally to identify and support value improvement efforts to support business goals

Support post market surveillance of products through competent authority communication

Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs

Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities

Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation

Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness

Regulatory requests including certification of compliance and product inquires

Change Control - lead documentation change orders per quality system requirements

Risk Management - use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis

Foster/sustain 'Voice of Quality' and 'Quality 1st mindset'

Recommend and make changes to QMS procedures, SOPs, Work Instructions and other related documents as necessary

Performs other functions as required

Qualification

FDA regulationsISO 13485ISO 14971Statistical analysisRisk managementLeadership experienceProblem-solvingTeam collaboration

Required

BS Industrial Engineering, Engineering or Business Degree and 4-7 years of medical device experience in Quality Operations, or equivalent experience preferred

FDA regulations, ISO 13485, ISO 14971

Adheres to Resolution Medical's Core Beliefs and all safety and quality requirements