Quality Management Systems Specialist

1 month ago

Burlingame, United States SPECTRAFORCE Full time

\Job Title: Quality Management Systems Specialist

Duration: 12 Months (possibility for extension for another year)

Location: Burlingame, CA (Remote with 10% Travel)

Responsibilities

  • This subject matter expert will work cross functionally in a tech company
  • The ideal candidate will act as the leader for the growing Medical Devices QMS team, draft SOPs, technical documents and have deep domain experience in digital health and software as a medical device (SaMD).
  • Leverage operational experience to meet quality and regulatory goals, define processes within a medical device product area residing within a larger consumer electronics division
  • Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for electromechanical and SaMD products
  • Collaborate with systems and software engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and device master record (DMR) deliverables
  • Guide medical device development teams in their execution strategy for Design and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports)

Qualifications

  • Bachelor’s Degree in Technical Science, min MS degree in quality assurance or equivalent
  • 10 years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development)
  • Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR
  • Experience authoring technical reports, business correspondence and standard operating procedures
  • Proven communication skills
  • Experience presenting clearly and persuasively to technical and non-technical audience

Key Projects/Day-to-Day Responsibilities:

  • Work on SAMD
  • The ideal candidate will act as the leader for the growing Medical Devices QMS team, draft SOPs, technical documents and have deep domain experience in digital health and software as a medical device (SAMD).
  • Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR
  • Compelling Story & Candidate Value Proposition

What makes this role interesting:

  • Work on a cutting-edge digital health tech
  • Developing AI/ML based software medical device
  • Work with Direct to consumer health wearables product experience

Must-Have Skills

  • Exp with SAMD – Software as medical device
  • Exp with Medial device QA system
  • Technical writing – for QA documentation / SOP’s

Nice-to-have Skills

  • Regulatory submission exp
  • Start up exp
  • Scrum exp

Years of Experience:

  • 10+ experience working in QA systems and QA for medical devices
  • Target job title: QA manager, QA compliance engineer, QA system Engineer, Look for someone with medica device engineering

Keywords:

  • Design history file, QMS quality management system, 510K, Software development, Agile, Scrum
  • Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR

Degrees/Certifications Required: Engineering degree in STEM field, Bio Medical engineer / Software engineer


About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.


Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.

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