Lead Quality Management Systems Engineer
Auburn Hills, MI - USA
Job Summary
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 sites critical Quality Systems 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 sites 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 sites 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:
Bachelors 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 e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a 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 drivers 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 () the Federal Trade Commission identity theft hotline () 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.
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Required Experience:
IC
About Company
At Jabil we strive to be the most technologically advanced and trusted manufacturing solutions provider.