Quality Manager

Specialty Appliances Orthodontic Laboratory; Tulsa (OK); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Disability Insurance

Job summary

Specialty Appliances Orthodontic Laboratory seeks a Quality Manager to lead the QMS for dental medical device manufacturing in Oklahoma. You will ensure FDA/ISO compliance, drive continuous improvement, and act as liaison with regulators while reporting to the Director of Quality & Regulatory Affairs.

The role spans Tulsa and Moore, Oklahoma, with primary duties in Tulsa, guiding risk management, inspections, audits, and supplier quality to support product safety and regulatory alignment.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field from an accredited institution.
• Progressive quality management experience in regulated industries with increasing responsibility.
• Experience managing a complete QMS in a regulated manufacturing environment.
• Experience with orthodontic or dental medical devices preferred.
• Proven track record leading inspections, regulated audits, and customer audits.
• CAPA management, risk management, and regulatory submissions experience.
• Strong leadership and people management skills.
• Excellent written and verbal communication for complex quality data.
• Ability to manage multiple priorities in a fast-paced environment.
• Cross-functional collaboration and influencing without authority.

Responsibilities

• Lead and maintain the QMS ensuring compliance with FDA, ISO 13485 and regulatory standards.
• Develop, update, and improve QMS policies, procedures, and controlled documents.
• Serve as Management Representative and liaison for regulatory agencies and Notified Bodies.
• Lead Management Review, presenting QMS metrics, risks, and improvement plans.
• Establish, track, and report quality KPIs to drive data-based decisions.
• Oversee document control and change control with proper approvals and traceability.
• Manage nonconformance investigations, dispositions, and trends.
• Oversee the CAPA program with root cause analysis and effectiveness checks.
• Lead customer complaint handling, investigations, and regulatory reporting.
• Plan, execute and manage internal audits and host external audits.
• Manage supplier quality, including qualification, monitoring, SCARs, and supplier audits.
• Ensure compliance with FDA QSR/QMSR, ISO 13485, ISO 14971 and evolving requirements.
• Oversee product risk management per ISO 14971 throughout lifecycle.
• Support design controls and ensure proper DHF, DMR, and DHR documentation.
• Oversee inspections to ensure product conformance and release.
• Manage calibration and maintenance of inspection/test equipment.
• Support process validations (IQ/OQ/PQ) and ensure validated state.
• Monitor environmental controls to protect product quality and safety.
• Review and approve batch/lot records and release docs.
• Lead, mentor, and develop Quality staff and training effectiveness.
• Develop and manage Quality department budget and resources.
• Participate in new product development and transfers for regulatory alignment.
• Ensure product identification, traceability, and labeling meet regulatory/UDI requirements.

Skills

Quality Management

Regulatory Compliance

Leadership

CAPA Management

Audits

Process Improvement

Data Analysis

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field

Job description

The Quality Manager is responsible for the overall leadership, management, and strategic direction of the Quality Management System (QMS) for dental medical device manufacturing in Oklahoma. This role ensures that all products meet the highest standards of quality, safety, and regulatory compliance for our two northeastern locations. The Quality Manager serves as the Management Representative and is accountable for maintaining compliance with FDA, ISO, and other applicable regulatory requirements while driving a culture of continuous improvement across the organization. This position reports to the Director of Quality and Regulatory Affairs.

This role will be worked between our Tulsa and Moore, Oklahoma locations; primarily in Tulsa.

Specialty Appliances is a fast-paced, high-growth, private-equity-backed company looking for strong team members to support our Quality and Regulatory Affairs team in Oklahoma!

In this role, you will…

• Lead and maintain the Quality Management System (QMS) ensuring compliance with FDA, ISO 13485, and regulatory standards.
• Develop, update, and improve QMS policies, procedures, and controlled documents across all functions.
• Serve as Management Representative and primary liaison for regulatory agencies and Notified Bodies.
• Lead Management Review, presenting QMS performance metrics, risks, and improvement plans.
• Establish, track, and report quality KPIs to drive data‑based decisions.
• Oversee document control and change control, ensuring proper approvals, revision history, and traceability.
• Manage nonconformance investigations, dispositions, and trends to identify systemic issues.
• Oversee the CAPA program including root cause analysis, corrective actions, and effectiveness checks.
• Lead customer complaint handling, investigations, trending, and regulatory reporting (MDR/Vigilance).
• Plan, execute, and manage the internal audit program and host external audits.
• Manage supplier quality, including qualification, monitoring, SCARs, and supplier audits.
• Ensure compliance with FDA QSR/QMSR, ISO 13485, ISO 14971, and evolving regulatory requirements.
• Oversee product risk management activities per ISO 14971 throughout the product lifecycle.
• Support design controls and ensure proper DHF, DMR, and DHR documentation.
• Oversee incoming, in‑process, and final inspections to ensure product conformance.
• Manage calibration and preventive maintenance of inspection and test equipment.
• Support process validations (IQ/OQ/PQ) and ensure validated state is maintained.
• Monitor environmental controls to protect product quality and safety.
• Review and approve batch/lot records and release documentation for finished goods.
• Lead, mentor, and develop Quality department staff, including performance management.
• Oversee the training program ensuring compliance, competency, and documented training effectiveness.
• Develop and manage the Quality department budget and resource planning.
• Participate in new product development and transfers, ensuring regulatory and quality alignment.
• Ensure product identification, traceability, and labeling meet regulatory and UDI requirements.

In this role, you will need to have…

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field from an accredited institution, preferred.
• Demonstrated progressive experience in quality management within regulated industry (ISO 9001, ISO 13485, ISO 14971, IATF 16949, AS9100) with increasing levels of responsibility.
• Demonstrated experience managing a complete Quality Management System in a regulated manufacturing environment.
• Experience with orthodontic, dental, or Class I medical devices is highly preferred.
• Proven track record of successfully leading inspections, regulated audits, and customer audits.
• Experience with CAPA management, complaint handling, risk management (ISO 14971), and regulatory submissions.
• Strong leadership and people management skills with the ability to motivate, develop, and hold teams accountable.
• Excellent written and verbal communication skills, with the ability to present complex quality data to all levels of the organization.
• Strong analytical and problem‑solving skills with a detail‑oriented approach.
• Ability to manage multiple priorities and projects simultaneously in a fast‑paced manufacturing environment.
• Demonstrated ability to work cross‑functionally and influence without direct authority.
• Sound judgment and decision‑making skills, particularly in situations involving product quality and patient safety.

What We Offer

• Medical, Dental, and Vision Insurance
• Short-term and Long-term Disability Insurance