Quality Systems Manager

Jabil Malaysia; Cockeysville (MD); On-site; USD 121,000 - 218,000; Full time

Job summary

Jabil is seeking a quality engineering leader to champion the development, implementation and maintenance of the quality management system. You will specialize in ISO 13485 and CFR 820.30, define document structures, oversee validation activities, and train teams worldwide.

You will partner with functional groups, drive continuous improvement and ensure regulatory compliance across medical device programs. You will provide strong quality focus while managing all activities affecting quality, and

Qualifications

• Strong knowledge of ISO 13485 and CFR 820.30.
• Experience with quality requirements for combination/diagnostic devices.
• Proven leadership and management experience.
• Excellent communication and stakeholder management.
• Experience in verification/validation processes and process improvement.

Responsibilities

• Define, develop and maintain the quality system and its processes.
• Lead ISO 13485 and CFR 820.30 compliance initiatives across programs.
• Oversee process validation and design verification activities and documentation.
• Provide training and guidance to sites globally on QMS improvements.
• Partner with cross-functional teams to deliver quality outcomes.

Skills

Leadership

Regulatory knowledge

Quality management

Communication

Project management

Analytical thinking

Education

Bachelor’s Degree in engineering

Master’s degree preferred

Job description

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's 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 SUMMARYProvide 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 RESPONSIBILITIESFUNCTIONAL MANAGEMENT RESPONSIBILITIESBusiness Strategy and Direction:Know and understand the department’s 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 customer’s 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 QMSProvide 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 QUALIFICATIONSKNOWLEDGE 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 company’s 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 experienceEDUCATION & EXPERIENCE REQUIREMENTSBachelor’s Degree in engineering required; Master’s 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 $121,300 - $218,300. 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.BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.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.Accessibility AccommodationIf 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 [e-mail] or calling 727-803-7988 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.#whereyoubelong#AWorldofPossibilities