Lead Quality Management Systems Engineer

Jabil is seeking a Lead Quality Management Systems Engineer to work in Auburn Hills, MI.

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.

• 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, ESD
  20:20, 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.

• 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.

• 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.

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