Lead Quality Management Systems Engineer
Jabil · Auburn Hills, MI ·
- Seniority
- Lead
- Category
- Software engineering
Jabil is seeking a Lead Quality Management Systems Engineer to work in Auburn Hills, MI.
How will you make an impact?
As a Lead Quality Management Systems Engineer with Jabil, you will be responsible for the coordination and supervision of the site’s critical Quality System’s programs including (but not limited to) Calibration, ESD, Preventative Maintenance, Device History Records and Document Control.
What will you do?
Manage the team members that support the site’s Quality Systems programs including (but not limited to) CAPA system and auditing tool, Calibration/ESD/PM systems, Device History Record and document control. Provide meaningful and timely feedback on employees’ performance, including completing and conducting annual performance appraisals.
Ensure compliance with Regulatory and ISO standards (21 CFR part 820, 21 CFR part 11, ISO 13485, ISO 9001, ESD20:20, etc.).
Lead continuous improvement efforts to meet regulatory and business needs.
Maintain and lead the updates of documents related to quality system policies, procedures and work instructions. Lead the evaluation of Quality System document gap assessments and align with the Quality Manager on making updates to local documentation, as necessary.
Assist in the continual analysis of the site’s Quality Management System to ensure full compliance to quality, environmental, health and safety procedures and regulatory requirements
Support internal, external, and customer audits as necessary
Ensure appropriate staffing levels for Quality System teams.
Ensure customer/workcell needs are being met.
Comply, document and interpret data required to monitor and analyze process related performance metrics. Provides JOS and key plant metric updates. Leads the development and maintenance of JOS metrics for the Quality Systems department.
Provide technical guidance on more complex issues; interprets and ensures consistent application of organizational quality policies
Collaborate with other departments to carry out corrective and/or preventive actions
May be required to perform independent internal audits in the absence of the lead auditor.
Review protocols and closure reports for qualifications and validations, as required.
Work safely at all times and comply with Environmental Health and Safety standards and work practices along with all other work rules
Other duties as they may be assigned.
How will you get here?
Education & Experience:
Bachelor's degree in Engineering, Science, or a related technical field.
A minimum of 6 years of experience in a quality assurance or quality systems role within a manufacturing or quality engineering environment.
At least 2 years of supervisory or leadership experience is strongly preferred.
Knowledge, Skills, Abilities:
Solid understanding of Quality Management Systems (QMS) principles and methodologies (e.g., ISO 9001, ISO 13485, AS9100).
Experience of participating in internal or external audits.
Familiarity with root cause analysis techniques and problem-solving methodologies.
Knowledge of and practical application of quality theory and practices
Knowledge of CAPA and process validation procedures.
Excellent written and verbal communication skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Ability to speak and present to internal and external customers.
Detail-oriented with strong organizational skills.
Strong project management, applied statistical, interpretive and problem resolution skills.
Benefits you will receive while working with Jabil:
Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:
Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
401K match
Employee Stock Purchase Plan
Paid Time Off
Tuition Reimbursement
Life, AD&D, and Disability Insurance
Commuter Benefits
Employee Assistance Program
Pet Insurance
Adoption Assistance
Annual Merit Increases
Community Volunteer Opportunities
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 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 [email protected] 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
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