CAREER PORTAL

IVD Quality System Specialist

IVD Quality Systems Specialist
Hercules, CA- HYBRID
6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $35-40/hr - Depending on Education and Experience

Shift: Hybrid - 8-5, 3 days on site
Summary:
The Quality System Specialist will assist in the updating and consolidation of legacy product technical and risk management files related to IVDR.

Responsibilities:

• Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards.
• Coordinating and facilitating meetings with cross-functional stakeholders as necessary to gather information and data required for the completeness and accuracy of risk profiles for existing hazards, and identifying new risks and hazards as needed. Escalate events to Management that require additional inputs or mitigations.
• Supporting the migration of product risk management files into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF binders in coordination with DHF migration efforts.
• Assessing legacy technical and risk documentation and identifying gaps relative to initial IVDR transitional activities versus new guidance documents and updates to global quality management procedures.
• Supporting other IVDR-related technical documentation updates and gap assessments as required, including identification of legacy design and development documentation and migration into eQMS as necessary (document scanning, etc.).
• Working in a dynamic environment and supporting cross-functional teams with shifting priorities.
• Taking initiative, working independently, and demonstrating ownership and accountability for assigned activities.

Skills or Requirements:

• Associate degree in Biology, Chemistry, Engineering or a related field.
• 2+ years experience in regulated manufacturing or equivalent education and experience.
• Knowledge of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Familiarity with device/drug/biotech manufacturing processes.
• Detail-oriented with strong organizational, project management, multitasking abilities.
• Skills in decision making, time management, communication, and computer use.
• Proficient in Microsoft Office, Visio, and Excel.
• SalesForce, Veeva, EtQ and/or SAP experience are desirable.
• Experience in product design and development and risk management a plus.

What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Estimated Min Rate: $28.00
Estimated Max Rate: $40.00


Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, 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.

Visit https://www.yoh.com/applicants-with-disabilities  to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.