38 applicants

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Company

Original Job Post

Spacelabs Healthcare · 3 days ago

Senior Quality Assurance Engineer

Snoqualmie, WA

Full-time

Onsite

Senior Level

7+ years exp

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Responsibilities

Provide leadership and support for Quality Management System performance.

Review Design Control and Risk Management outputs to ensure compliance.

Monitor and ensure efficient manufacturing processes.

Facilitate processing of Nonconforming Material Reports and Rework Orders.

Facilitate product distribution and installation controls.

Ensure post-market activities and defect handling procedures.

Conduct Internal Quality Audits and support regulatory compliance.

Participate in management reviews and third-party audit activities.

Maintain and update quality system procedures for compliance.

Qualification

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Quality engineeringMedical device regulatoryQuality management systemsTechnical files maintenanceRisk managementUsability engineeringDesign history filesChange control documentationStatistical analysisSoftware as a medical deviceDesign controlsNew product developmentQMS complianceCommunicationSelf-motivatedOrganizedChange Agent ExperienceFDA RegulationsMDDMDRMDSAPEN ISO 13485EN ISO 14971IEC 62366-1EN ISO 15223EN ISO 20417EN 62304CybersecurityIEC 60601-1ISO 27001

Required

Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).

7+ years related Quality / Engineering work experience.

5+ years of experience with medical device regulatory and quality and Quality Management Systems.

Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.

Experience with statistical analysis.

Knowledge of Software as a Medical Device (SaMD) or Software within a device required.

Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards.

Proven ability to communicate effectively with staff at all levels of the organization.

Self-motivated and organized.

Preferred

Experience acting as a Change Agent.

Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001 preferred.

Creative problem solving, flexibility, and good negotiation skills.

Some travel may be necessary both domestic and international, less than 5%.

Benefits

Life at OSI

Company

Spacelabs Healthcare

Spacelabs Healthcare To inspire the world to bring the best care experience to patients and families.

Founded in 1958

Snoqualmie, Washington, USA

1,001-5,000 employees

http://www.spacelabshealthcare.com

H1B Sponsorship

Spacelabs Healthcare 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 (5)

2022 (6)

2021 (6)

2020 (2)