89 applicants

Company

Original Job Post

BD · 2 days ago

Senior Quality Engineer

USA GA - Covington BMD

Full-time

Hybrid

Senior Level

5+ years exp

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Health CareMedical Device

Comp. & Benefits

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Responsibilities

Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.

Provides Quality Assurance leadership for Project Teams or Quality Department.

Builds, reviews and approves Quality System Documents (CAPA, Audits).

Crafts, reviews and approves Product Documents, such as Design History Files.

Creates, reviews, and approves Protocols, Process and Product Validations, Stability. Creates, reviews, and approves Risk Assessments such as FMEA, FMECA or FTA. Protocols, Software Validation documents.

Mentors staff.

Provides supervision to technicians and engineers.

Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.

Performs Internal or Supplier Quality System Audits.

Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.

Performs Complaint review and investigation as the need arises.

Tracks and trends Quality Indicators.

Collaborates with manufacturing facility or other Division Facilities.

Serves as Independent QA Reviewer and Chairperson for Design Reviews.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Capital system experienceFDA regulated environmentProduct designQuality EngineeringASQ CertificationInternational suppliers/manufacturersInterpreting regulationsStatistical analysisIEC 60601 standards

Required

BS/MS Engineering (EE or ME)

Capital system experience (Electro-mechanical)

5 years of experience in FDA regulated environment, with 3 years of product design experience

2 years of Quality Engineering experience in a regulated environment

ASQ Certification

Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA

Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability

Demonstrated history of successfully interpreting regulations, and procedures

Demonstrated skill in statistical analysis and applied statistical methodologies

Knowledge and understanding of IEC 60601 standards

Company

BD

Glassdoor

3.9

BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.

Founded in 1897

Franklin Lakes, New Jersey, USA

10,001+ employees

https://www.bd.com

H1B Sponsorship

BD 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 (48)

2022 (142)

2021 (217)

2020 (149)