Quality Engineer IV - Assistant Quality Manager (Engineering)
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.
About Our Company
Nypro Healthcare, a Jabil company, offers healthcare and pharmaceutical customers the widest array of design and manufacturing capabilities in the industry. With more than 40 years of experience, our highly specialized teams meet the complex and regulated demands of the diagnostics, medical devices and pharmaceutical markets enabling the world's leading brands to fulfill their market potential. Nypro Healthcare's customer focused services range from ideation to device development support, engineering, supply chain optimization, vertical plastics and electronics to device assembly operations, all at our purpose-built facilities that support stringent healthcare requirements and protect our customers' intellectual property.
· Execute against the strategic vision and tactical plan for the department in support of Nypro Clinton goals and objectives. Responsible for the overall direction, coordination and evaluation of department NPI Quality Engineering activities.
· Represents the quality function in the deployment of new or modified systems, 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, Part 11.
Essential Duties & Responsibilities
· Plan, promote and participate in activities to support local and global safety practices and programs
· 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 (SME) for Verification, Commissioning, Qualification, Validation of new or modified systems, including equipment, test methods, environmental controls and software, etc…
· Serve as a Department Subject Matter Expert (SME) for Advanced Quality Planning (AQP)
· Serve as a Department Action Team Leader for Corrective Actions (CA), Preventative Actions (PA) and A3 Projects
· As assigned, responsible for direct supervision of department Commercial Quality Engineers, as well as temporary workforce performing those functions as necessary. Responsibilities include:
o Interviewing, hiring and training department resources
o Planning, assigning and directing work
o Employee performance appraisals, acknowledgement/rewarding and disciplinary actions
o Addressing complaints and resolving problems
o Allocation of department resources in support of Nypro Clinton commercial objectives / initiatives
· Responsible for development, maintenance and site compliance of the Master Validation Plan (MVP), Commissioning and Qualification Plan (C&Q), Project Validation Plan (PVP), etc… as established through local site and customer requirements
· 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
The following are requirements of the posted job requirements
· B.S. in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation Engineering experience), with 5 – 10 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
· Must be able to translate customer requirements / specifications into the manufacturing level batch / device history record documentation.
· 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 Master Validation Planning (MVP), Commissioning and Qualification (C&Q), etc… for asset / system deployment
· Applied experience in Measurement System Analysis (MSA) and Gage Repeatability and Reproducibility (GR&R)
· Applied experience in high-speed automation asset deployment and retrofitting
· Applied experience working with medical devices, combination devices, and pharmaceutical delivery systems
· Applied experience in industry regulated under standards such as cGMP/QSR, ISO13485 and 21CFR820, Part 11
· Applied resource management experience within a project team environment
The following are not required but considered valued characteristics in job candidates:
· Experience in high-speed automation asset deployment and retrofitting
· Experience in Master Validation Planning (MVP), Commissioning and Qualification (C&Q), etc… for asset / system deployment
· Experience with SolidWorks, Creo, AutoCad or other Computer Aided Drafting (CAD) software packages
· Experience with Coordinate Measurement Machine (CMM), Vision System, Comparators, Drop Indicators, Calipers, Force Testers, PEVCO, Keyence VR
· Experience with Minitab, LotusNotes, SAP, Predisys SPC, and Adobe Writer applications
· Experience with hard gauging and hand tools for taking measurements
· Background in Medical Device Manufacturing, ISO13485, High-Speed Automation and Assembly, 21CFR820, Part 11
· Certified Internal / Lead Auditor in ISO13485:2016
· ASQ certifications such as Certified Quality Manager, Certified Auditor, 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.