Supplier Quality Engineer

POSITION SUMMARY

The Supplier Quality Engineer develops implements and maintains supplier quality management practices that meet Agiliti customer and regulatory requirements. This role partners crossfunctionally with quality engineering and suppliers to support product development ensure compliance and drive continuous improvement across the supply base.

PRIMARY OBJECTIVES AND RESPONSIBILITIES

• Participate in Quality Management System (QMS) activities including document control records management training and competency nonconforming material reports (NCMRs) and corrective and preventive actions (CAPAs).
• Lead supplier qualification selection and approval processes to ensure compliance with internal and external requirements.
• Collaborate with quality and engineering teams throughout product development including supplier new product qualification validation and process validation activities.
• Apply structured problemsolving methodologies to identify prioritize communicate and resolve supplier quality issues.
• Monitor supplier performance by collecting analyzing and reporting predefined quality metrics.
• Ensure supplier containment actions and corrective measures meet Agiliti quality and regulatory standards.
• Create and manage project schedules deliver milestones and support continuous improvement initiatives.
• Conduct supplier quality audits and travel as needed to support issue resolution and compliance activities.

QUALIFICATIONS

• Bachelors degree in Engineering or Life Sciences.
• Minimum of three (3) years of experience in Quality Engineering including participation in IQ OQ PQ and process validation activities.
• At least two (2) years of experience in supplier quality management and supporting new product development projects.
• Experience working within an ISO 13485compliant Quality Management System and medical device manufacturing environment.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Prior experience auditing suppliers and managing Supplier Corrective and Preventive Actions (SCAPAs).

KNOWLEDGE SKILLS AND ABILITIES

• Comprehensive understanding of quality system requirements under 21 CFR Part 820 and ISO 13485.
• Strong analytical and problemsolving skills including application of basic statistical techniques.
• Proficiency in Microsoft Office applications.
• Excellent technical writing verbal communication and presentation skills.
• Strong project management and facilitation abilities.
• High attention to detail with the ability to work independently and manage multiple priorities.
• Demonstrated ability to build effective crossfunctional partnerships internally and with suppliers.

DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department and the company.

It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race color religion gender identity sex sexual orientation national origin age physical or mental disability genetic information marital status status as a veteran military service or any other characteristic protected by applicable federal state or local civil rights addition Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agilitis investigation of such reports. Affirmative Action Policy Statements

You may be required to obtain certain vaccinations or provide proof of current vaccination status based on customer and/or company requirements. If vaccination is required Agiliti will provide specific directions and cover the expense at a participating clinic. Please note this includes the COVID-19 vaccination.

Agiliti offers a robust suite of benefits for regular full-time non-union employees including: health insurance options for Medical Dental & Vision plans Short- and Long-Term Disability plans Flexible Spending Accounts Health Savings Accounts Life Insurance Options Paid Time Off 401K Saving Plan with employer match Employee Discounts Tuition Reimbursement Daily Pay program Employee Assistance Program and wellness programs.

Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.

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Agiliti

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This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. For sales positions this range combines the base salary and the target incentive pay. The actual pay offered may vary depending on several factors including geographic location experience job-related knowledge skills and related factors. Dependent on the position offered short-term and/or long-term incentives may be provided as part of the compensation. Applicants should apply via Agilitis internal or external career site.