Quality Engineer-Medical Device Job in Redwood City 94063, California Us

Opportunity for a Quality Engineer, reporting to Sr. Director, Quality with a medical device company located in Redwood City, CA. This is a direct hire position with benefits.

 

This position would work closely and partner with internal departments to efficiently deliver safe and effective medical device designs for manufacturing in line with the company’s policies and procedures.  Provide quality assurance support to all functions with focus on design control compliance in accordance with ISO 13485, 21 CFR Part 820 and 93/42/EEC, and process improvements.  This includes supporting project teams on new and existing product development activities to ensure that the product is designed and developed in accordance with customer, corporate and regulatory guidelines, and working with Manufacturing Engineering to improve processes where possible.

 

Responsibilities:

  1. Actively participating in all design control activities, to include:

a.     design reviews to ensure that the design meets the intended customer satisfaction in use and that all requirements are documented;

b.     technical development of test plans;

c.     Risk Analysis/Failure Mode and Effects Analysis (FMEA) and/or Fault Tree Analysis (FTA);

d.     perform Design Verification Testing (DVT)

e.     coordinate/perform validation activities for:

                          i.        biocompatibility testing,

                         ii.        packaging validation,

                        iii.        stability (shelf life) studies,

                        iv.        sterilization validation,

                         v.        test method validation,

f.      identify testing and analysis required for the finished device to ensure device conformance to product specifications;

g.     develop the device quality plan to ensure that all elements of the quality system regulations are appropriately described and managed.

  1. Provide support to Operations

a.     Assist in qualifying molds and fixtures

b.     Implement process improvements

  1. Evaluate/investigate and document investigation results for all field failures and device complaints.
  2. Review and disposition Engineering Change Orders (ECO), Non-conforming Material Reports (NCMRs), and CAPAs.
  3. Perform internal and supplier audits.
  4. Participate in third party audits (FDA, FDB, NSAI, etc.).
  5. Participate in the implementation and improvement of the quality system.
  6. Provide technical support to the quality inspection group.
  7. Manage the calibration and preventive maintenance activities.

a.     Schedule calibration and PM

b.     Coordinate calibration with outside services

c.     Update records

 

Qualifications:

1.    Bachelor of Science degree in related field

  1. 5-7 years in working in a Medical Device or biotech industry
  2. Ability to perform multiple tasks concurrently with accuracy
  3. Experience and involvement with complaint investigations, including MDRs and vigilance reporting.
  4. Must have demonstrated hands-on experience in:

a.     design verification and validation,

b.     hazard/risk analysis,

c.     design/process FMEA,

d.     reliability and stability testing,

e.     FDA Good Manufacturing Practices (GMP).

  1. Clear and effective communication skills

a.     Proficiency in MS Word, Excel and Power Point required

b.     High attention to detail and accuracy is required

  1. Experience with Minitab and/or Statgraphics a plus.

 

 

There is no relocation package planned for this position so Bay Area candidates are preferred though others with closely matching skill sets will be considered.