Director, Quality & Quality Systems

This position is open to our Grand Rapids, Mi or Clinton Twp, Mi location.

Summary of Function:

The Director of Quality & Quality Systems is responsible for leading and overseeing the organization's Quality Management System (QMS) across multiple manufacturing sites. This role combines strategic quality leadership with hands-on quality systems management to ensure compliance with FDA regulations, ISO 13485 standards, customer requirements, and internal quality objectives. The Director will lead the consolidation and implementation of a unified quality system across all sites, drive continuous improvement initiatives, reduce Cost of Quality (COQ), and foster a culture of quality excellence throughout the organization. This position provides leadership for quality assurance, regulatory compliance, audit readiness, supplier quality, validation activities, and quality systems performance. Job Mission Lead the consolidation and implementation of a unified quality system across multiple manufacturing sites. Ensure compliance with FDA regulations and

ISO 13485

standards, drive continuous improvement, and foster a culture of quality.

Major Duties and Responsibilities:

Quality Leadership & Strategy Lead Quality Assurance activities across all Medbio manufacturing sites. Develop, implement, maintain, and continuously improve a consolidated Quality Management System (QMS). Establish and execute quality strategies aligned with business objectives and regulatory requirements. Drive initiatives to reduce Cost of Quality (COQ) and improve operational effectiveness. Ensure customer expectations and quality requirements are consistently met. Foster a proactive culture of quality, accountability, and continuous improvement. Quality Management System (QMS) Maintain and improve the QMS in compliance with

ISO 13485, FDA

regulations, and applicable regulatory standards. Own and manage core QMS processes, including: CAPA (Corrective and Preventive Actions) Non-Conforming Product (NCP) Complaint Handling Deviations and Investigations Change Control Document Control Standardize quality workflows, processes, and systems across all manufacturing locations. Establish quality metrics and KPIs to monitor system effectiveness and drive corrective actions. Utilize Root Cause identification, data analysis and trending to identify improvement opportunities. Cross-Functional & Multi-Site Collaboration Lead quality system harmonization and process alignment initiatives between sites. Collaborate with Engineering, Commercial, Supply Chain, and Operations teams across all facilities. Provide strategic guidance and leadership on quality-related matters throughout the organization. Regulatory Compliance & Audits Ensure ongoing compliance with

FDA, ISO

13485, and other applicable regulatory and customer requirements.

Lead and support:

Internal audits Customer audits Supplier audits Regulatory inspections Registrar and notified body audits Maintain enterprise-wide audit readiness across all sites. Drive timely and effective corrective action responses and audit closure activities. Document Control & Change Management Oversee document control systems, ensuring accuracy, revision control, and compliance. Manage Engineering Change Orders (ECOs) and quality system changes. Ensure quality management software systems are properly configured, maintained, and continuously improved. Validation & Metrology Define and oversee validation and qualification activities, including: IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) Ensure validation activities meet regulatory and internal standards. Maintain accountability for metrology and calibration systems across all sites. Identify opportunities to improve efficiency of qualification activities through standardization, consolidation and coordination. Training & Team Leadership Develop and implement quality training programs to ensure employee compliance and competency. Define organizational resource needs and support hiring, onboarding, and retention of quality personnel. Lead performance evaluations, coaching, development planning, and succession planning for the Quality team. Support employee development through mentoring and continuous learning initiatives. Manage hiring, disciplinary actions, and termination processes within the Quality organization. Supplier & Customer Quality Partner with Supply Chain and Operations to: Qualify new suppliers and vendors Maintain approved supplier lists Monitor supplier quality performance Ensure supplier compliance with quality and regulatory requirements.

Manage customer quality requirements including:

Quality agreements Surveys and questionnaires Customer-specific compliance obligations Serve as the escalation point for customer quality concerns and compliance matters. Key Performance Indicators (KPIs) CAPA closure time and effectiveness Audit findings and closure timelines Supplier quality performance Complaint resolution time Training compliance rates QMS effectiveness metrics Cost of Quality (COQ) reduction Customer quality performance metrics Regulatory inspection outcomes

Organizational Relationships:

Directly reports to the Vice President, Engineering & Quality, In addition, will have a daily working relationship with the Management Team. Experience and/or

Educational Requirements:

Bachelor's degree in Engineering, Quality, Life Sciences, or related field required; advanced degree preferred. Progressive quality leadership experience in medical device or regulated manufacturing environments.

Strong working knowledge of:

ISO 13485 FDA

Quality System Regulations (21 CFR Part 820) Risk management principles Validation methodologies Audit management Experience managing multi-site quality systems and teams preferred. Demonstrated success implementing and improving enterprise QMS software (IQMS/DelmiaWorks or Intellect) . Strong leadership, communication, organizational, and problem-solving skills. Experience with electronic QMS platforms and quality data analysis tools preferred.

Physical Requirements/Work Environment:

Multi-site manufacturing environment 30% travel required between facilities and customer/supplier locations Participation in audits and regulatory inspections required

Pay:

$140,000.00 - $170,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person