Senior Quality Engineer Job

SENIOR QUALITY ENGINEER needed for a contract opportunity with Yoh's client located in South San Francisco, CA.

THE BIG PICTURE:

- Will be responsible for reviewing existing hardcopy Design History Files
- Will work with the Quality single-point-of-contact

WHAT YOU'LL BE DOING:

- The DHF auditor will be responsible for reviewing existing hardcopy Design History Files to assess them for regulatory compliance.
- The DHF auditor will work with the Quality single-point-of-contact (SPOC) and device teams to resolve any compliance issues.
- Quality System Document Review

a) Read and understand Roche Pharmaceutical Quality System (PQS) documentation applicable to device development

b) Apply PQS document intent when assessing Design History Files

- Design History File Assessment

a) Review hardcopy Design History File document for device development projects to assess their quality and compliance to regulations

b) Document all compliance gaps

c) Categorize gaps as non-compliance to PQS, inadequate implementation of project plans, or non-compliance to regulations

d) Prioritize gaps as high, medium, or low regulatory risk

- Resolve Compliance Issues

a) Use risk based approach to determine which issues to resolve

b) Work with Quality SPOC and device teams to find practical solutions to compliance gaps

- Make Recommendations for Improvement

a) Based on audit findings, make recommendations for improvement in DHF management

b) Support implementation of the accepted recommendations

WHAT YOU NEED TO BRING TO THE TABLE:

- Experience with DHF audits and remediation
- Minimum ten (10) years' experience in medical device or combination product design and development environment required, with emphasis on design control.
- Must be detail-oriented with strong organizational skills
- Strong interpersonal skills, verbal and written communications.
- Design History File Audit, Design History File Remediation, Design Control, Medical Device, Combination Product, Document Control, Document Management, Quality, and Regulatory

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelor's Degree required
- Preference for Engineering or technical field.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a DayJ2W: CLINICAL

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