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Document Control Specialist
Job Order #16722
San Francisco, California - Added Sep 25, 2019

Full Description:

We have an immediate need for a skilled Document Control Specialist for our North Bay client in the Pharmaceutical industry. The ideal candidate will have a combination of skills, the most important being experience working with Medical Devices with respect to ISO and CFR regulations, knowledge of change controls, and solid technical writing skills. This candidate will join the ranks of a groundbreaking Pharmaceutical and Biotechnology company that has been well established within industry.

 

 

Document Control Specialist

 

 

Required:
TOP 4 Keys:
1) Medical Device or Pharmaceutical Company/Industry exp. preferred, within an Engineering and/or Eng. Doc Dept.
2) Solid understanding of the Life Cycle of Product Development within a Pharma and/or Med Device company environment – Preferred :
Understand EDMS (Electronic Data Management/Control System/s) within Medical Field preferred,
Know Quality, MDLCM (Medical Device LifeCycle Management) knowledge - OR - PLCM (Pharma LifeCycle Mgt.) knowledge.
3) Know Change Controls such as ECO’s, ECN’s, ECR’s, etc…
4) Excellent Writing Skills – Solid experience with Researching, Collecting Data, and Writing, relative to regulations and standards (FDA, ISO, etc.).
Solid Technical Writing skills w/ SOPs, Work Instructions, Technical Reports, FMEA’s, etc…

• MS Word, MS Excel, MS Outlook, VISIO – Proficiency.
• Great communication skills – verbal, written, and with graphical techniques.
• Effective working in a cross-functional group.
• 5-8 years of experience working in Pharmaceutical or Medical Device industries, in a Doc Control and/or Quality Dept. role.
• BS in Engineering or Sciences, or equivalent combination of education and experience.

Desired:
• FDA Regulations and ISO Standards knowledge a big plus.
• Understanding of the Complaints loop within a Medical Type company a plus.
o Risk-assessments knowledge based on product complaint data processing a plus.
• CAPA or 510K exp. a big plus.

Job Description:
• Help manage a combination of products (medical/pharma devices) post-market activities, which include – Risk Management, product complaints, adverse events, quarterly system management review, annual product review, and assessment of impacts from the evolving regulatory landscape to product line documentation.
• All types of documentation and writing, including taking great notes in meetings, and transforming those notes into team-action.
• Support pre-market design and development programs.
• Design and develop combination-products and related regulatory requirements governing human-use and commercialization.
o Support pre-market activities in the design and development of combination products.
• Organize, analyze, and report on quality metrics for market products that contain device components and assemblies.
• Perform required post-market risk-management activity to maintain risk profiles and associated controls for all device products.
• Periodic assessment of regulatory requirements against marketed products and associated controlled documents.
• Facilitate revisions to SOPs as required, to support the current state of business.
• Perhaps work into a QE role.

 

 

Are you available?  Please send your most current resume to Leonard at resumes@mbg.com

Please reference JO#16722LJ

Mainz Brady Group provides technology staffing solutions to the best known companies in Software Development, Finance, Electronics/Manufacturing, Retail, R&D, Services, Biotechnology, Healthcare and Telecommunications.

We specialize in Information Technology, Technical Sales and Marketing Staffing on a Contract, Contract to Hire, and Direct Hire basis.

To see a complete listing of all current openings please visit us at www.mbg.com/

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