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Compliance Specialist

1 month ago

Burlingame, United States US Tech Solutions Full time

Job Details:

Job Title: Compliance Specialist V/ Quality Management Systems Specialist

Job Location: Burlingame, CA

Job Duration: 12 months contract

Pay rate: $80.00-$85.00/hr. on W2 without benefits


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.


About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,

national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Shantanu Sharma

Email:shantanus@ustechsolutionsinc.com

Job ID # 24-18155