Job Summary

Sr. Quality Engineer

  • Location:
    San Diego , California
  • Category:
    Quality Assurance
  • Contract Type:
  • Job reference:

Sr. Quality Engineer
San Diego, CA
12-month contract

As directed by the Quality Manager, the Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Primary Responsibilities and Duties
1 Consistent application of technical principles, theories, concepts and quality sciences / tools.
2 Proven problem-solving skills
3 Makes measurable improvements to company processes and procedures
4 Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
5 Is a team member representing Quality on new product development and sustaining engineering projects.
6 Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
7 Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices (Auditor-in-Training)

Scope of Responsibility:
Contributes to the completion of specific programs and projects.
Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers
Prepares/Revises policies/procedures.
May be expected to make presentations

Sphere of Influence:
Works under general direction.
Independently determines and develops approach to solutions.
May provide guidance and work direction to lower level project developers
Designs and performs development working independently within defined parameters with minimal supervision required

Requires a minimum of a Bachelors Degree

Experience A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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