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Automation NPI & Commercial Quality Manager (Medical Device)

Req ID: J2275791

  • Location
    Clinton, Massachusetts, United States of America
  • Category Quality Group
  • Posted Friday, June 11, 2021
  • Type Full time

Job Description

Job Description

SUMMARY
Drive continuous improvement through the development and implementation of Quality processes, systems, tools and techniques. Provide exceptional support to customers, team members, and shareholders. Execute against the strategic vision and tactical plan for the department in support of Jabil Clinton and Devens goals and objectives. Responsible for the overall direction, coordination and evaluation of department NPI and Commercial Quality Engineering activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

LEADERSHIP AND MANAGEMENT RESPONSIBILITIES

Recruitment and Retention
·         Recruit, interview and hire Quality staff as needed to support business volumes.
·         Monitor team member turnover; identify key factors that can be improved; make improvements.

Employee and Team Development
·         Identify individual and team strengths and development needs on an ongoing basis.
·         Create and/or validate training curriculum in area of responsibility.
·         Coach and mentor Quality Engineering staff to deliver excellence to every internal and external customer.
·         Create and manage succession plans for Quality function.

Performance Management
·         Establish clear measurable goals and objectives by which to determine individual and team results (i.e. operational metrics, results against project timelines, training documentation, attendance records, knowledge of operational roles and responsibilities, personal development goals).
·         Solicit ongoing feedback from Workcell Manager (WCM), Business Unit Manager (BUM), peers and team member on team member’s contribution to the Workcell team. Provide ongoing coaching and counseling to team member based on feedback.
·         Perform team member evaluations professionally and on time.
·         Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals (A3's and Blitzes).
·         Coordinate activities of large teams and keep them focused in times of crises.
·         Ensure recognition and rewards are managed fairly and consistently in area of responsibility. Consistent participation in Jabil RRR global recognition program.

Communication
·         Provide weekly communication forum for the exchange of ideas and information with the department.
·         Organize verbal and written ideas clearly and use an appropriate business style.
·         Ask questions; encourage input from staff.
·         Assess communication style of individual team members and adapt own communication style accordingly.

  • Communicate directly with customers both internal/external as needed to ensure successful results/outcomes.


FUNCTIONAL MANAGEMENT RESPONSIBILITIES

Business Strategy and Direction
·         Know and understand the campus strategic directions. Drive to meet or exceed department/site goals and KPI's. 
·         Develop an understanding of the workcell business strategy as it pertains to Quality.
·         Build strong, collaborative and respectful relationships with BUM, PM, WCM, and Operations Manager.

  • 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…
    • Handling of product / process non-conformances, complaints, deviations and engineering release orders, etc…
    • Advanced Quality Planning (AQP) activities


Cost Management
·         Identify creative ways to reduce cost by streamlining processes and systems (i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems) without compromising Quality.
·         Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value.
·         Provide feedback to peers (BUMs, WCMs, Functional Managers (FMs) on cost and cost trends.

Forecast Development and Accuracy
·         Prepare timely and accurate forecasts for the department which includes multiple cost centers. Ensure labor/headcount forecasts are supported by data.
·         Compare forward forecast results to historical actual results for trend assessment and analysis.

  • Prepare for monthly cost variance meetings, explain any large variances between what was forecasted versus actual.


TECHNICAL MANAGEMENT RESPONSIBILITIES

·         Drive continuous improvement through trend reporting analysis and metrics management.
·         Assess the adequacy of data gathering methods utilized by the workcells.
·         Assure that procedures and work instructions are efficient and not redundant.
·         Offer new ideas and suggestions for improvement. Identify and implement new practices and processes that are “best in field.”
·         Demonstrate a commitment to customer service; anticipate, meet, and exceed expectations by solving problems quickly and effectively; making customer issues a priority.
·         Understand and drive regulatory and compliance to (i.e. regulatory requirements surrounding ISO13485, ISO14000, FDA 21CFR Part 820).

Drive support for CAPA, complaints, NCMR process and timeliness.
·         Establish new measurement systems if/where possible.
·         Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.
·         Ensure 100% adherence to all company policies and procedures (i.e. Health and Safety, Quality).
·         Ensure all sensitive and confidential information is handled appropriately.
·         Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
·         Comply and follow all procedures within the company security policy.

MINIMUM 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 a minimum of 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.

  • Applied knowledge in the application of Statistical Process Controls (SPC)

  • Applied experience in Measurement System Analysis (MSA) and Gage Repeatability and Reproducibility (GR&R)

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

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