Post Market Quality Specialist II

Irvine or Hercules, CA- HYBRID

6 month W2 contract (with potential to extend or transition to perm)

Pay rate : $45-52 / hour - Depending on Education and Experience

Summary :

LOCATION- Irvine or Hercules, CA

Hybrid 2-3 days onsite

As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports.

This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner.

The candidate will use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.

In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities.

Responsibilities :

• Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including :
• Analysis of post market data and reviewing completed reports with business partners.
• Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
• Maintain, archive and completed controlled quality records.
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
• Facilitate and / or chair local / regional PMS Board meetings.
• Support various QMS and PMS projects (local and global) as needed.
• Support internal / external audits as needed.

Skills or Requirements :

• Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
• Understanding of product post market surveillance requirements for IVD products a plus.
• Working knowledge of device / drug / biotech manufacturing processes.
• Detail-oriented and ability to multitask.
• Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
• Advanced technical writing and word processing skills.
• Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus

Education / Experience :

• Bachelor's degree or equivalent in a related life science / technical / engineering discipline or equivalent preferred.
• 5 years experience in a regulated manufacturing industry or equivalent combination of education and experience.

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

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.

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https : / / www.yoh.com / applicants-with-disabilities

Last updated : 2024-06-04