Quality Systems Specialist (Medical Device) at Jabil Inc. in Clinton, Massachusetts

Job Description:

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

The position of Quality Systems Engineer / Quality Engineer / QMS Administrator is responsible for supporting the product development process and quality management system at Jabil Healthcare Engineering & Technology (JHET) Clinton. Individual is expected to have strong background in ISO 9001, ISO 13485, ISO 14971 and/or 21CFR830.20 to facilitate organization and project team compliance with the JHET Clinton Quality Management System (QMS). Role will report to Quality Discipline Lead.

PRIMARY DUTIES AND RESPONSIBILITIES

- Manage QMS processes and documentation including, but not limited to training records, calibration records, approved supplier list (ASL), supplier records, CAD/drawings product data management (PDM), engineering change orders (ECO), non-conforming material review (NCMR), corrective and preventative actions (CAPA) and document control

- Develop and/or update QMS procedures and templates

- Identify, qualify and manage suppliers

- Lead internal audits and document reviews

- Support notified body / ISO registrar and client audits

- Establish, encourage use of and participate in continuous improvement of processes, procedures and standard tools related to design controls, risk management, supplier management and prototype assembly at Jabil

- Develop, participate in and/or review project design control (product requirements, design inputs, design & development plans, design reviews etc.) and risk management (plan, HARA, FMEA, report, etc.) documentation with project teams.

- Collect and manage content of project design history files (DHF)

- Provide guidance to project teams and clients on compliance with the QMS

- Contribute to project planning through proposal development and review

MINIMUM EDUCATIONAL REQUIREMENTS
Bachelors degree in engineering, science or technology related field
 

MINIMUM PRIOR WORK EXPERIENCE TYPICALLY REQUIRED

- Three to five years of experience working in product development environment with quality management system and/or design control requirements

- A history of developing products with multi-disciplinary teams

- Experience with medical industry regulation, risk management and design controls (ISO 9001, ISO 13485, ISO 14971, FDA, CFR, etc.)

ESSENTIAL SKILLS REQUIRED:

- Motivated, takes initiative

- Professional in manner and appearance

- Good interpersonal skills

- Excellent written and verbal communication skills

- Strong mechanical aptitude

- Learns and understands information quickly

- Attention to detail

- Commitment to excellence and high ethical standards

- Strong organizational, problem-solving, and analytical skills

- Ability to manage priorities and support multiple projects effectively

- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

- Passionate about working in a team with other disciplines (Business Development, Research, Human Factors, Design, Engineering, Implementation)

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Salary: