Jobs via Dice
Senior QA Engineer – Medical Device
Location: Bellevue, WA | Duration: Long Term Contract
Overview TekShapers is seeking a Senior QA Engineer to lead quality engineering activities for hardware and software products in the medical device industry.
Responsibilities
Provide quality engineering leadership for software and hardware product development teams.
Lead design control, risk management, and other QA activities for new product development projects.
Establish and nurture strong relationships with cross‑functional product development team members.
Lead the development and maintenance of the Risk Management File (RMF).
Provide QA input, review, and approval of the Design History File (DHF) and associated documentation.
Provide guidance on statistical methods and analyses for design verification and validation.
Serve as SME for software quality and collaborate on code reviews, software security analysis, and BOM.
Participate in design reviews to ensure effective development, transfer, and maintenance of the product throughout the lifecycle.
Support the successful transfer and hyper‑care phase of design and design modifications into production / field deployment.
Provide QA support for anomalies (e.g., software bugs, cybersecurity vulnerabilities) encountered in production and development projects.
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs related to the design control process.
Provide QA support for released products, interfacing with customer support representatives and account executives as necessary.
Qualifications
8+ years of progressive QA experience in the medical device industry with hands‑on support for hardware and software development.
B.S./M.S. in a relevant engineering field (e.g., biomedical, software, electrical) or equivalent scientific degree.
Experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
Experience in design, development, verification, validation, and test activities for medical device hardware and software.
Experience in deploying quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with proven ability to wear many hats.
Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Comfortable working in a high‑growth company with rapidly evolving needs, responsibilities, and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab).
Certified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.
Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure preferred.
Education and Experience 8+ years of progressive QA experience in the medical device industry with hands‑on support for hardware and software development.
B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
Physical Demands and Work Environment Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Equal Opportunity Employer TekShapers is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
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Overview TekShapers is seeking a Senior QA Engineer to lead quality engineering activities for hardware and software products in the medical device industry.
Responsibilities
Provide quality engineering leadership for software and hardware product development teams.
Lead design control, risk management, and other QA activities for new product development projects.
Establish and nurture strong relationships with cross‑functional product development team members.
Lead the development and maintenance of the Risk Management File (RMF).
Provide QA input, review, and approval of the Design History File (DHF) and associated documentation.
Provide guidance on statistical methods and analyses for design verification and validation.
Serve as SME for software quality and collaborate on code reviews, software security analysis, and BOM.
Participate in design reviews to ensure effective development, transfer, and maintenance of the product throughout the lifecycle.
Support the successful transfer and hyper‑care phase of design and design modifications into production / field deployment.
Provide QA support for anomalies (e.g., software bugs, cybersecurity vulnerabilities) encountered in production and development projects.
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs related to the design control process.
Provide QA support for released products, interfacing with customer support representatives and account executives as necessary.
Qualifications
8+ years of progressive QA experience in the medical device industry with hands‑on support for hardware and software development.
B.S./M.S. in a relevant engineering field (e.g., biomedical, software, electrical) or equivalent scientific degree.
Experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
Experience in design, development, verification, validation, and test activities for medical device hardware and software.
Experience in deploying quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with proven ability to wear many hats.
Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Comfortable working in a high‑growth company with rapidly evolving needs, responsibilities, and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab).
Certified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.
Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure preferred.
Education and Experience 8+ years of progressive QA experience in the medical device industry with hands‑on support for hardware and software development.
B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
Physical Demands and Work Environment Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Equal Opportunity Employer TekShapers is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
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