Spacelabs Healthcare · 10 hours ago
Sr. Quality Assurance Engineer
Snoqualmie, WA
Full-time
Hybrid
Senior Level
7+ years expSpacelabs Healthcare is dedicated to innovation in healthcare technology for improved clinical and economic outcomes. The Sr. Quality Assurance Engineer will oversee the Quality Management System to ensure the quality of products and services, fostering a culture of excellence and compliance throughout the organization.
Health CareInformation Technology
Hiring Manager
Tina Cooley
Responsibilities
To ensure the release of safe, effective and compliant medical devices, the Sr. Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking. They will be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records
Ensure the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance
Review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance
Ensure product Design Change activities move ahead in a timely and effective manner
Monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling
Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders
Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log
Ensure post-market activities ensure intended device performance
Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities
Responsible for conducting QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities
Ensure high quality of products and services, by implementing and maintaining the Quality Management System
Ensure that QMS activities are risk-based
Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.)
Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within the project teams on new or sustaining product development projects
Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files
Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products
Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records
Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions
Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance
Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s)
Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements
Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements
Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration
Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP
Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings
Participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Senior Quality Assurance Engineers shall recognize potential impacts to health or device efficacy (“Safety Issues”), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices
Upholds the Company’s core values of Integrity, Innovation, Accountability, and Teamwork
Demonstrates behavior consistent with the Company’s Code of Ethics and Conduct
It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem
Duties may be modified or assigned at any time to meet the needs of the business
Qualification
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
Experience with medical device electrical safety standards
Creative problem solving, flexibility, and good negotiation skills
Some travel may be necessary both domestic and international, less than 5%
Company
Spacelabs Healthcare
Spacelabs Healthcare To inspire the world to bring the best care experience to patients and families.
1001-5000 employees
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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (11)
2023 (5)
2022 (6)
2021 (7)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$4M2023-10-30Grant· $4M
2004-03-22Acquired
Leadership Team
Thomas Faris
VP Global Quality and Regulatory Affairs
Recent News
EIN Presswire
2025-06-26
Company data provided by crunchbase