Quality Operations Leader

Johnson & Johnson; Manatí (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Quality Operations Leader in Manatí, PR, to oversee quality standards in manufacturing. This role involves providing leadership and technical support to ensure compliance with regulatory requirements while fostering teamwork and continuous improvement. The ideal candidate will possess strong leadership skills, technical writing abilities, and a solid background in quality assurance within regulated environments. Join a forward-thinking company dedicated to innovation and excellence in healthcare solutions, where your contributions will directly impact patient wellness and product quality.

Qualifications

• 6+ years of experience in a regulated environment with supervisory roles.
• Strong technical writing and leadership skills required.

Responsibilities

• Lead quality assurance efforts to maintain high standards in manufacturing.
• Administer testing and control of raw materials and finished products.

Skills

Leadership and management skills

Technical writing

Bilingual (Spanish & English)

Interpretation of QSR and ISO Standards

Statistical and analytical problem solving

Education

Bachelor’s degree in Science

Bachelor’s degree in Engineering

Tools

Quality Assurance tools

Compliance software

Statistical analysis software

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Manatí, Puerto Rico, United States of America, San Lorenzo, Puerto Rico, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Quality Operations Leader to be in Manatí, PR.

Under the direction of the Site Quality Lead and with the objective of maintaining high quality standards for the product manufacturing process and in compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance. Provide guidance during the design, development, enhancement, revision, and implementation of the quality systems efficiently manufacturing products and processes. Is the deputy Management representative as required. Directly supervises Quality Engineers (different levels/pay grades), Quality Team Leaders, Quality Technicians and/or non-exempts associates in day-to-day activities supporting manufacturing lines, operator certification program, incoming and finished goods inspections; all in accordance with applicable regulations and Ethicon written specification at quality standards. Provide support and expertise on problem solving, process improvements and in the usage of quality tools.

You will be responsible for:

• Administers the deployment and utilization of resources for tactical day to day work. This includes but not limited to working with Operations, Materials Management, Technical
• Operations and Quality Assurance to facilitate testing and release of finished goods
• Administers the testing and controlling of raw material, finished product quality and in process quality, assuring compliance with company standards and applicable regulations.
• Responsible for the evaluation and disposition of WIP and questionable raw materials.
• Advice and guide Operations on inspection and testing procedures, provide direction and recommendations when required.
• Initiates and maintains interplant communications of quality issues.
• Maintains close interaction and network with peers at other Plants to address quality related issues.
• Administers available resources to achieve a reliable, efficient, and productive operation.
• Facilitates QA support to new product launches to assure a successful implementation.
• Fosters teamwork and supports total associate involvement.
• Assists the Site Quality Lead in the preparation of the Annual Department Budget.
• Resides as a backup to the Site Quality Lead for signature authority and meeting
• Approved purchases and expense reports submitted by direct reports.
• Analyzes Plant reports for significant quality trends and reports conclusions.
• Supports Internal Regulatory Compliance Function as required.
• Monitors Good Housekeeping practices, good manufacturing practices and employee
• Participates in the developments of procedures, specifications, cost control planning, self inspection methods and systems for QA. Enforces implements and follows up on all procedure and specifications.
• Approves specification and process changes per applicable procedures.
• Provide feedback to operations on problems related to quality and/or compliance.
• Support/imitates investigations of non-conformances.
• Supports operations in evaluation and implementation of action plans to eliminate root causes of non-conformances.
• Support validations as required.
• Provides support to Plant wide initiatives.
• Actively supports other Plant functions in the implementation of company programs and
• Assists Site Quality Lead in the preparation of the Performance/Potential Appraisals for the Quality Operations related functions.
• Acts as a designated Site Quality Lead when needed.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)

Qualifications

Education

• A minimum of a Bachelor’s degree in Science is required. Bachelor’s degree in Engineering is preferred.

Experience and Skills

Required

• A minimum of 6 years of related work experience in a regulated environment.
• 3+ years of supervisory experience.
• Advanced computer skills and use of software application(s).
• Fully Bilingual (Spanish & English)
• Strong technical writing skills are required.
• Leadership and management skills.
• Interpretation and application of QSR and ISO Standards.
• Ability to work cooperatively with coworkers and the public.
• Ability to perform duties in accordance with policies and procedures and in compliance with civil rights requirements.

Preferred

• Experience in the Medical Device industry or medical field.
• ASQ Certified Quality Auditor (CQA) preferred, or ISO Certified Lead Auditor
• Excellent communication and interpersonal relation skills.
• Statistical and analytical problem solving.

Other

• Availability to work various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.
• This position may require up to a 20% of domestic travel between Ethicon Locations (Manatí, PR and San Lorenzo, PR) and/or other locations based on business needs.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

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