The Quality Manager is responsible for developing, implementing, and maintaining quality control processes, procedures, and policies to ensure products and services meet or exceed customer expectations and comply with applicable standards and regulations. This role involves cross-functional coordination, data analysis, and leadership of the quality team to drive continuous improvement across the organization.

Key Responsibilities:

Serve as the Management Representative in compliance with

ISO 13485

2003 and

ISO/TS 16949

2009 standards. Ensure the Quality Management System (QMS) is effectively established, implemented, maintained, and aligned with the QEM, QEP, and QEWI documentation. Promote awareness of regulatory and customer requirements throughout the organization. Monitor compliance with relevant ISO standards, implement changes as necessary, and keep the organization up to date with revisions. Lead customer-facing quality functions, including root cause analysis, liability determination, and corrective action implementation through 8D or similar problem-solving methodologies. Assign and oversee tasks to Quality Engineers, Analysts, and Auditors; monitor progress and evaluate effectiveness. Collaborate with Engineering, Production, and Sales to understand inspection demands and support accurate quoting for new projects. Establish and maintain Preventative Maintenance activities within quality-controlled areas, typically medical and/or assembly. Manage quality team staffing including hiring, onboarding, performance reviews, training, time-off approvals, and resolution of HR issues in coordination with Human Resources. Conduct routine department meetings to communicate updates, corporate/local news, and address employee questions. Ensure organizational readiness for external audits and maintain quality certifications and customer approvals. Coordinate with external vendors and manufacturers for the repair, calibration, or replacement of measurement equipment; submit purchase requisitions as needed. Lead Material Review Board (MRB) meetings and manage the Notice of Discrepancy (NOD) process, ensuring timely and effective resolution and documentation.

Qualifications:

Bachelor's degree in Engineering, Business, or a related field. Minimum of 5 years of experience in quality control, quality assurance, or related discipline. Demonstrated leadership and team management experience. Strong analytical, problem-solving, and data-driven decision-making skills. Excellent communication and interpersonal skills. In-depth knowledge of

ISO 13485, ISO/TS

16949, and QMS best practices.

Pay:

$80,000.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Vision insurance

Location:

Bellevue, OH 44811 (Required) Ability to

Commute:

Bellevue, OH 44811 (Required)

Work Location:

In person