Review and releases IQOQPQs through collaboration with the Equipment team.
Support the tracking and trending relevant quality metrics as assigned.
Support investigations, root cause analysis, and documentation of findings on Quality Events.
Conduct lab walkthroughs on a periodic basis and report and follow up on findings.
Effectively influences (by serving as a peer mentor) and trains employees on basic releases and processes.
Supports internal and external audits via gathering and preparation of audit material.
Support additional responsibilities as assigned.
Ability to be on-site to inspect products/materials and release lots.
Follow regulatory and ISO 13485 requirements.
Complexity & Problem Solving
Executes tasks/assignments that have clear and established processes and procedures. At times, tasks/assignments require occasional adaptation beyond established processes and procedures.
Collaboration & Interaction
Follows established procedures on routine work, receives instructions only on new assignments.
Typical Degree & Years of Experience
Bachelors degree (or equivalent) in a scientific /engineering related field
2-3 years of experience in the medical device/pharmaceutical/biotech industry.
Minimum 2 years of Quality Assurance or Regulatory Compliance (e.g. GCP, cGMP, GLP) experience.
Experience working and/or supporting production/laboratories a plus.
Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, MDD, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
Familiarity with Confluence and JIRA applications desired.
Strong written and verbal communication skills.
Analytical and problem-solving skills.
Proven ability to work cross-functionally to achieve business outcomes.
