68 applicants

Company

Original Job Post

Leica Microsystems · 4 days ago

QA Manager

Durham, NC

Full-time

Hybrid

Mid Level

$125K/yr - $135K/yr

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Responsibilities

Ensure that quality system requirements are established and maintained per the applicable regulations.

Ensure adequate application of design control requirements during new product development and throughout the product life cycle.

Review QMS-relevant design control documentation, including design transfer and design change documentation.

Provide support during product design and sustainment to establish compliant and audit robust design documentation.

Perform training on QMS requirements related to design control, including design transfer and design change procedures.

Qualification

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QMSQuality AssuranceFDA RegulationsMedical Device Regulatory RequirementsEuropean UnionCommunicationProblem-Solving

Required

Proven experience in QMS and/ or quality assurance with medical electrical devices in an FDA-regulated industry or an equivalent combination of education and experience

Bachelor’s degree (BA/BS) or equivalent in science, engineering or equivalent

Experience in a global/ matrix environment or cross-functional teams in the medical device industry

Knowledge of medical device regulatory requirements in the United States and European Union

Great communication skills and availability to travel 10% of the time

Benefits

Paid Time Off

Medical/Dental/Vision Insurance

401(k)

Bonus/Incentive Pay

Company

Leica Microsystems

Glassdoor

3.3

Leica Microsystems designs and produces precision optics systems for the analysis of microstructures. It is a sub-organization of Danaher.

Founded in 1997

Wetzlar, Hessen, DEU

1,001-5,000 employees

http://www.leica-microsystems.com

H1B Sponsorship

Leica Microsystems 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 (4)

2022 (5)

2021 (7)

2020 (4)