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Company

Original Job Post

Johnson & Johnson · 1 week ago

Staff Quality System Engineer

Irving, TX

Full-time

Onsite

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Health CareMedical Device

H1B Sponsorship

Actively Hiring

Comp. & Benefits

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Responsibilities

Establishing and maintaining policies and procedures to ensure compliance with regulations and standards.

Coordinating recall strategy plan definition and recall activities.

Handling and carrying out the issues escalations process.

Reporting field actions metrics to appropriate review boards.

Leading, maintaining, improving, and standardizing Quality Systems.

Implementing/modifying quality systems to address changing Regulations or industry standard.

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.

Medical device manufacturingISO 13485QSR 820 FDAExecutive briefingsInterpersonal relationsCommunicationProblem-solvingGMP/ISO regulationsValidation regulationsASQ certificationSix Sigma experienceProcess Excellence toolsSix Sigma Green Belt CertifiedSix Sigma Black Belt Certified

Required

A Bachelor’s degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.

A minimum of five (5) years of proven experience in medical device manufacturing or related industry experience is required.

Prior experience in ISO 13485 and or QSR 820 FDA regulated environment is required.

Excellent interpersonal relations and communication skills.

Strong oral and written communications skills with ability to speak to broad, non‐technical audiences that are both internal and external personnel.

Skilled at preparing executive briefings and broad communications.

Preferred

A detailed and thorough understanding of GMP/ISO regulations and validation regulations.

American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools.

Six Sigma Green/Black Belt Certified.

This position is located in El Paso Texas; Irving Texas or Plymouth Minnesota and may require up to 10% domestic or international travel.

Company

Johnson & Johnson

Glassdoor

4.2

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.

Founded in 1886

New Brunswick, New Jersey, USA

10,001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson 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 (43)

2022 (55)

2021 (40)

2020 (30)