Assistant Quality Manager - Nypro Healthcare

At Jabil, we empower the brands who empower the world – it’s our reason for being and the guiding force that’s driving us to become the most technologically advanced manufacturing solutions provider on the planet.  Whether we’re serving one of the world’s biggest and best known brands or the coolest tech startups, our resolve never wavers. We share common desires with these brands: to make the world a better, safer and cleaner place.

 

Job Summary

Execute against the strategic vision and tactical plan for the department in support of NP Medical goals and objectives. Responsible for the overall direction, coordination and evaluation of department New Product Introduction, Batch Release, and Sustaining Quality Engineering activities.

Represents the quality function in the deployment of new or modified products, serving as a key contributor to new program / product introduction delivery activities.

Represents the quality function in the operational sustaining activities, serving as a facilitator and driver of continuous improvement and problem resolution activities.

Ensure complete compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO13485 and 21CFR820, and MDD/EU MDR.

 

Essential Duties & Responsibilities

Act as a change agent and participant in continuous improvement activities towards customer focus, process planning and improvement, and employee empowerment

Serve as a Department Subject Matter Expert for Design Verification & Validation, Risk Analysis, statistical analysis, and test method validation.

Serve as a Department Action Team Leader for Corrective Actions and Preventative Actions projects

Promote and participate in activities to support local and global safety practices and programs

As assigned, responsible for direct supervision of department Quality Engineers and technicians, as well as temporary workforce performing those functions as necessary.

 

Responsibilities include:

  • Interviewing, hiring, and training department resources
  • Planning, assigning and directing work
  • Employee performance appraisals, acknowledgement/rewarding and disciplinary actions
  • Addressing complaints and resolving problems
  • Allocation of department resources in support of NP Medical commercial objectives / initiatives
  • Plan, promote and participate in program / project change control operational sustaining activities including the creation, maintenance and compliance of standard operating procedures, work instructions, purchasing specifications, incoming inspection records, inspection / quality plans, etc.
  • Plan, promote and participate in commercial support problem solving activities including resolution of area non-conforming product / process events, process change / deviation authorizations, product quarantine events and complaint investigations, etc.
  • As appropriate, may be required to participate as an auditee in internal, customer and third-party audits for those processes and systems within their scope of influence
  • As appropriate, may be required to directly interface with customers, suppliers, and other local site departmental resources at all levels of these organizations.
  • Other responsibilities to be assigned from time to time as needed, based on the evolution of the company and the requirements of the department / position.

 

Education & Experience Requirements

  • B.S. in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation Engineering experience), with 7 or more years quality engineering/assurance experience and 0 – 3 years in a supervisory capacity.
  • Strong communication and problem-solving skills required.
  • Strong technical writing skills, specifically related to creation / revision of work instructions, procedures, testing protocol and summary report creation
  • Effective leader possessing strong interpersonal and conflict management skills.

 

The following are preferred in job candidates:

  • Applied experience in Quality Management Systems (QMS) and functions: Corrective Action and Preventative Action (CAPA), Material Review Board (MRB), Non-Conforming Material Reports (NCMR), Complaints, Internal and External Audits.
  • Applied experience in Verification and Validation planning, Measurement System Analysis, and Gage Repeatability and Reproducibility.
  • Applied experience in high-speed automation asset deployment and retrofitting.
  • Applied experience working with medical devices,  
  • Applied experience in regulated industry under standards such as ISO13485 or 21CFR 820, or EU requirements.
  • Applied resource management experience within a project team environment.
  • Certified Internal / Lead Auditor in ISO13485:2016.
  • ASQ certifications, such as Certified Quality Manager, Certified Auditor, Certified Reliability.
  • Engineer, or Certified Quality Engineer.

 

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.