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Company

Original Job Post

CooperVision · 3 days ago

Sr. Quality Engineer

Pleasanton, CA

Full-time, Contract

Onsite

Senior Level

$95K/yr - $127K/yr

5+ years exp

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Health CareManufacturing

H1B Sponsorship

Hiring Manager

Rebecca (Becca) Kayser

Insider Connection @CooperVision

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

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.

Qualification

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FDA regulationsISO13485MDSAPMDRCAPA experienceAudit experienceQuality AssuranceMedical Device QMSProblem solvingDetail orientedInterpersonal skillsTeamworkFast-paced work environment

Required

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

Minimum 5 years’ Quality Assurance experience in an ISO environment

Minimum 2 years’ Medical Device QMS audit

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

Benefits

Comprehensive benefits

Wellness programs

Company

CooperVision

Glassdoor

3.8

CooperVision is one of the world’s leading manufacturers of soft contact lenses and related products and services. It is a sub-organization of The Cooper Companies.

Founded in 1980

Fairport, New York, USA

5,001-10,000 employees

http://coopervision.com

H1B Sponsorship

CooperVision has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (9)

2022 (7)

2021 (12)

2020 (13)