Supplier Quality Assurance Manager

The Opportunity

This position works out of our Des Plaines, IL location (in office) in the Abbott Molecular Diagnostics, Quality Assurance Group.

The person hired in this role will Manage the Supplier Quality Assurance Team.

They will serve as the main SQA contact during the internal and external audits.

What You’ll Work On

Manage the development and administration of departmental activities of Supplier Assurance while maintaining compliance to, and driving continuous improvement of, related quality assurance programs, policies, process, procedures and controls.

Manage the Supplier Quality Operations.

Ensure we are compliant with Applicable Regulations ISO13485 and CFR820

Define and communicate overall vision and cascaded objectives for the departments.

Staff, train, develop and manage employees.

Assess and manage all resource needs within the department.

Manage all activities related to Supplier Quality in accordance to policy, including supplier selection and

evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments,

supplier performance reviews and supplier development.

Lead employees in driving continuous improvement in department processes and establishing departmental objectives to

meet divisional goals.

Develop and maintain department operating budgets.

Manage expenses to within budget, while meeting established

objectives.

Define, justify, acquire and implement inspection test equipment to meet specified needs.

Re-deploy employees as priorities change to meet Division objectives.

Develop, train, implement and continuously approve upon department policies and procedures.

Ensure departmental compliance with Division SOPs and procedures.

Ensure timely and thorough review of product / process changes.

Provide routine communications with department employees to assure awareness.

Provide timely performance & developmental evaluations of departmental staff.

Assess and develop employee skillsets to assure effective support.

Work cross functionally in identifying and resolving technical issues.

Provide routine department objectives and performance metrics reporting to management as defined.

Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and

professional work environment.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,

operating procedures, processes, and task assignments. Maintains positive and cooperative communications and

collaboration with all levels of employees, customers, contractors, and vendors.

Serve as SQA SME during FDA, ISO and other audits.

Strong knowledge of CFR 820, ISO 9001 and ISO 13485 regulations and standards.

Managerial experience a must.

Required Qualifications

Bachelor's Degree or Related field or an equivalent combination of education and work experience

Minimum 5 years Related to supplied product quality within an FDA / ISO certified environment.

Multi-tasks, prioritizes and meets deadlines in timely manner.

Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Travel up to 30-50% travel.

Minimum experience 7+ years managerial experience in an FDA regulated environment including IVD and or Medical Devices.

Experience interfacing with FDA and ISO auditors a must.

ISO 13485 Certified Lead Auditor experience required.

Responsibility includes implementing and maintaining Supplier Control metrics. Prepare and present metrics in management review meetings.

Experience in Purchasing Controls / Supplier Quality a must.

Preferred Qualifications

Strong leadership skills to motivate and enable department employees in meeting objectives.

Strong written and verbal communication skills.

Experience in departmental budgeting and supervision / training / managing staff.

Experience with computers and software application knowledge consistent with engineering environments.

Experience working in a broader enterprise / cross division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Ability to work effectively within a team in a fast-paced changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.