Quality Systems Manager

At Jabil (NYSE: JBL) we are proud to be a trusted partner for the worlds top brands offering comprehensive engineering supply chain and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

JOB SUMMARY

Provide leadership for the development implementation communication and maintenance of elements of the quality system. Specialist in ISO 13485 and 21 CFR 820.30. Identify best practices define design implement and train top level document structure. Ensure compliance with all regulatory requirements in an effective timely and responsible manner. Provide a strong detailed quality focus as well as managing all work affecting quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES

FUNCTIONAL MANAGEMENT RESPONSIBILITIES

Business Strategy and Direction:

• Know and understand the departments worldwide strategic directions.
• Define develop and implement Quality Engineering strategies in partnership with all relevant functional groups.
• Provide regular updates to the Director on strategy execution.
• Serve as Deputy Management Representative.
• Customer Guidance:
• Ensure the team has a complete and accurate understanding of customers quality requirements and that a deliver plan is in place.
• Participate in defining where the group can provide value on programs both internally and externally.
• Support the process of design and development planning proposal writing and program budgeting.

TECHNICAL MANAGEMENT RESPONSIBILITIES

• Oversee and contribute to all departmental program process validation activities services and deliverables.
• Provide leadership and technical insight to grow departmental services (may include planning protocol and methods development data collection statistical analysis and report writing).
• Responsible for effective metrology support whether internal or external.
• Leverage Best Practices from programs and all Design sites to drive continuous improvement to the QMS.
• Support global training programs specific to each site by development and implementation of specialized training sessions for all applicable functions. (i.e. MFAT IQ/OQ/PQ DFMEA etc.)
• Conduct periodic review and maintenance of all documentation files; develop appropriate systems for worldwide document storage and access.
• Support Quality in maintaining and improving the QMS
• Provide guidance of implementing and maintaining Process Improvement and Optimization concentrating on proactive methodologies.
• Facilitate site adherence to all safety and health rules and regulations.
• Comply and follow all procedures within the company security policy.
• May perform other duties and responsibilities as assigned.

JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

Strong knowledge of ISO 13485 including Design Controls and CFR 820.30 and quality requirements for combination devices and diagnostic devices.
Solid understanding of Process Validation and Design Verification processes and practices.
Strong proficiency in determining logistics requirements to enable companys business goals and objectives with ability to devise and implement strategy to achieve targets.
Proven track record of verification and validation experience ideally in pharmaceutical or diagnostic industries.
Demonstrated leadership and management experience.
Strong and convincing communication skills.
Consulting experience


EDUCATION & EXPERIENCE REQUIREMENTS

• Bachelors Degree in engineering required; Masters degree preferred.
• Minimum 10 years experience with four years in management or leadership role preferred.
• Or a combination of education experience and/or training.

The pay range for this role is $121300 - $218300. Job-related non-discriminatory factors used to determine the actual offered rate include qualifications and experience geographic location education external market data and consideration of internal equity.

As part of the total rewards package Jabil offers benefits to enhance your health wealth and resilient self. These include medical dental and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly;401(k) retirement plan; and employee stock purchase plan.

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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 identity age disability genetic information veteran status or any other characteristic protected by law.

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