Document Control Technical Manager Job

DOCUMENT CONTROL TECHNICAL MANAGER needed for a contract opportunity with Yoh's client located in South San Francisco, CA.

THE BIG PICTURE:

- The Document Control Technical Manager will be responsible for reviewing design control documentation supporting the Design History File (DHF) for combination products (medical devices) to ensure compliance with internal Pharma Quality System (PQS) documents and relevant Health Authority expectations specifically device design controls. The candidate will closely interface with the document authors and Quality to ensure any issues are resolved prior to routing for approval in the electronic DHF system. The candidate will ensure that new documents entered into the eDHF are inspection-ready with respect to compliance with FDA and ISO regulations. The candidate may also supervise document control specialist(s).

TOP SKILLS SHOULD YOU POSSESS:

- Medical device
- Design Control

WHAT YOU'LL BE DOING:

- Develop solid expertise with global, company-wide Pharmaceutical Quality System (PQS) and business processes to apply to design and development documents for medical devices and combination products.
- Facilitate implementation of PQS documents and local impact assessment process
- Act as document submission coordinator for new design and development documents
- Edit documents to ensure alignment with formatting standards and quality requirements - Good Documentation Practices
- Check technical information in design and development documentation for compliance with PQS Document all compliance gaps and make recommendations for gap closure
- Work with authors to edit documents to bring them into compliance with PQS and design control regulations
- Perform supervisory activities for document control specialist(s), as required
- Perform other related duties (as defined by Device Development management) that may be required based on corporate, department, and business needs

WHAT YOU NEED TO BRING TO THE TABLE:

- B.S degree or equivalent; preference for engineering or technical field
- Minimum ten (10) years' experience in medical device or combination product design and development environment with emphasis on design control
- Extensive knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical standards relative to device development. Understanding of international regulations and standards is a plus.
- Knowledge and expertise in applying Combination Products GMP rule is desired
- Expertise in technical writing and editing
- Minimum three (3) years supervisory experience
- Must be detail-oriented with strong organizational skills
- Strong interpersonal, verbal, and written communications skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: CLINICAL; J2W: PROF

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