Sr. Quality Engineer - Contractor

Support key Quality functions for the CooperVision Pleasanton Facility, such as Quality Systems (Internal/external Audits, Metrics, CAPA, NCR).

• Provides support for conducting internal audits and tracking of action items.

• Coordinates KPI Meetings, CAPA Review Board and Management Review presentations - compiling data, creating slides, reviewing raw data as needed.

• Assists in root cause investigations

• Participates in internal audits

• Participates in external audits such as ISO 13485 and FDA 21 CFR part 820 inspections

• Performs other duties as assigned.

Knowledge, Skills and Abilities:

• Sound knowledge in applicable regulations and standards such as FDA 21 CFR part 820, ISO13485, MDSAP, MDR, etc.

• Good written, oral and interpersonal skills

• Ability to work in a cross functional team environment, including R&D, Pilot Manufacturing, Clinical and Engineering

• Must be detail oriented

• Must have prior CAPA experience

• Structured problem solving ability based on 6δ methodology

• Internal and external audit experience (ISO13485, FDA 21 CFR part 820, and MDSAP.)

• Will work under the guidance of the Site Quality Manager

• Ability to work in a challenging and fast-paced work environment

Work Environment:

• Office working environment

• Prolonged sitting in front of a computer

• Use of computer systems

Experience:

• Minimum 5 years' Quality Assurance experience in an ISO environment

• Minimum 2 years' Medical Device QMS audit

Education:

• Minimum Bachelor's degree or equivalent, preferably in a technical discipline

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $95,012 and $126,682 per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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