Jr Quality Associate (Medical Device/GMP/ISO regulations)

Hercules, CA ( Onsite 2-3 days- *Local candidates only)

$45hr ( Weekly pay! + Benefits )

6 month contract ( Excellent potential for permeant and extension)

Full-time: M-F Hybrid – onsite 3 days a week.

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives! The Quality Associate will help facilitate the updating and consolidation of legacy product risk management files related to IVDR.

How You'll Make An Impact:

• Facilitating risk management assessments, updating risk plans and reports, consolidation and updating product system hazard analysis files in accordance with established company procedures and applicable standards
• Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed.
• Escalate events to Management that require additional inputs or mitigations.
• Support product risk management file migration into the eQMS system including ensuring document meta data is accurate and files are accurately linked to legacy product DHF binders in coordination with DHF migration efforts.
• Assessing legacy risk documentation and identifying gaps against initial IVDR transitional activities versus new guidance documents and updates to global risk management procedures.
• Support other IVDR related technical documentation updates and gap assessments as required, including migration into eQMS as needed.
• Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities.
• A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them.

What You Bring:

• Bachelor’s degree or equivalent in a related technical or scientific discipline
• Local candidates only.
• 2-4years experience in Quality or Education related to Quality
• Understanding of Medical Device withing GMP ( Good manufacturing practices)
• Basic knowledge of and application of principles and theories of quality engineering.
• Understanding of ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820) preferred
• Basic understanding of risk management regulations, principles, and application.
• SAP experience a plus.
• Bonus: SAP, EtQ and/or Veeva experience a plus.
• Proficient in Microsoft Office, Livelink, Visio.