95 applicants

Company

Original Job Post

Envista Holdings Corporation · 3 days ago

Jr. Quality Engineer

United States of America, New Jersey, Mahwah

Full-time

Onsite

Entry Level

$67K/yr - $74K/yr

1+ years exp

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DentalMedical Device

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Responsibilities

Oversee/ensure exceptional service for internal customers

Follow all procedures (SOPs) and documentation related to the Quality Management System to ensure compliance to all standards

Develop and maintain procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance

Assist in the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, product performance, etc.

Address and investigate customer complaints according to the medical device regulations; FSA 21 CFR Part 820 and ISO 1348:2016, leading to process/product improvements

Assist in implementing process improvements by using problem-solving techniques, such as Problem Solving Process (PSP), Variation Reduction (VRK) and continuous improvement techniques such as Value Steam Mapping )VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma

Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)

Lead and/or support CAPA investigations and related corrective and preventative actions

Ensure training support and effectiveness for multiple functions throughout the organization

Work with Mahwah Leadership Team to ensure the Quality Management System training program is maintained as per regulatory requirements

Assist in the reporting of the effectiveness of the Quality Management System

Provide support for internal and external audits and inspections

Assist in ensuring department goals and objectives are reached

Report the status of the Quality Management System and other related issues on a regular basis to the Sr. QA Engineer and/or Site Quality Manager

Other duties as assigned by the Site Quality Manager

Qualification

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Quality EngineeringQuality Management SystemsProcess ImprovementManufacturing EnvironmentComputer SkillsSAPMicrosoft SuiteCollaborationTeamworkCommunicationAdaptabilityAgilityFDA CFR 820ISO 13485 2016GMPMDRRegulatory AuditsData ManagementStatistical Tools

Required

Bachelor’s degree in Engineering or related field, or equivalent combined education and experience

Minimum 1 year of experience as a Quality Engineer, or equivalent experience working with Quality Management Systems or with process/product improvements in a manufacturing environment

Strong Computer skills (SAP, Microsoft Suite)

Strong focus on collaboration and teamwork

Strong communication skills (Writing, Reading, Spoken) required

Excellent planning and organizational skills

Ability to adapt to change, agility

Preferred

Working knowledge of FDA CFR 820, ISO 13485:2016, GMP, MDR

Prior work experience in a regulated medical device or pharmaceutical environment preferred

Prior experience participating in regulatory audits a plus

Prior experience managing complex data sets or statistical tools a plus

Benefits

Annual performance bonus

Medical/dental/vision benefits

401K match

Company

Envista Holdings Corporation

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives.

Founded in 2004

Brea, California, USA

10,001+ employees

http://www.envistaco.com/

H1B Sponsorship

Envista Holdings Corporation 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 (2)

2022 (12)

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2020 (16)