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Johnson & Johnson · 20 hours ago

Senior Quality Systems Engineer

Bradley, WV

Full-time

Onsite

Mid, Senior Level

4+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. The Senior Quality Systems Engineer will provide guidance and support for the Quality Management System, ensuring compliance and collaboration with business partners.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Will serve as a Quality Systems subject matter expert, track and report action plan status/ completion as relates to quality systems improvement efforts

As needed, assist with creation, modification and improvement of Quality System procedures, work instructions and related documentation

Drive robust quality and compliance execution in the business and drive successful Q&C scorecard metrics by working closely with key stakeholders in the business

Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, Non-Conformance, and subsequent closure of investigations

Oversee all Compliance activity within the facility in conjunction with the Regulatory Compliance and Quality Operations groups. Liaise with management at all levels of the business and produce metrics and present data on site performance at meetings such as the weekly and monthly management meetings

Oversee the Customer Complaints system in conjunction with Complaints and Vigilance Manager, ensuring that timely closure is met whilst fully satisfying all Customer Complaint requirements

Ensure that the Quality System Review (QSR) continues to develop in terms of inputs and to ensure that any trends noted at this forum are challenged and acted upon

Responsible for conducting training in Quality Systems Management principles to business partners

Facilitates process of product issue assessment, quality review board preparation, and field action execution

Facilitates technical innovations to enhance Quality Systems and support business goals

Provides back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits)

Serves as a SME on the Quality Planning process, assists Quality Plan authors with the process, and files Quality Plans

Responsible for communicating business-related issues or opportunities to next management level

Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualification

Quality Management Systems (QMS)FDA regulationsISO 13485Project Management CertificationStatistical applications (Minitab)CoachingContinuous ImprovementBilingual EnglishBilingual SpanishCommunicationProblem Solving

Required

University Bachelor's Degree or Equivalent (preferably in Engineering, Math, Science, or Business)

4-6 years' experience in Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience

Minimum of 4+ years' experience in an FDA regulated industry (medical device, pharmaceutical, etc.)

Working knowledge of 21 CFR Part 820, 21 CFR 806, ISO 13485 and familiarity with ISO 14971

Broad-based technical knowledge and experience to work effectively with others in diverse areas of business (Operations, Quality, R&D, R.A., Engineering)

Ability to effectively prioritize and manage multiple activities and responsibilities

Must have outstanding business and technical communication skills (verbal, written, presentation)

Preferred

Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.)

American Society for Quality (ASQ) credentials

Bilingual (English and Spanish)

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ 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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)