Quality Manager - Medical

Technimark LLC; Asheboro (NC); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

Technimark LLC is seeking an experienced Quality Manager to lead the QMS for our Medical Device Manufacturing operations in Asheboro, North Carolina. You will ensure ISO 13485, FDA 21 CFR Part 820, and customer requirements are met while driving continuous improvement and operational excellence.

Reporting to the Senior Quality Manager, you will mentor Quality Engineers and Supervisors, manage CAPA and audits, lead validation activities, and build a culture of accountability and quality across

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related field.
• 5-10 years of quality experience with 3+ years in a management role.
• 5+ years of experience in Medical Device Manufacturing.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Experience leading Quality Management Systems in a regulated manufacturing environment.
• Experience with validation planning, protocol development, execution, and reporting.

Responsabilités

• Ensure the Quality Management System remains effective, compliant, and continuously improving.
• Report key quality metrics to leadership and drive improvement initiatives.
• Lead Master Validation Plan and validation strategy.
• Lead new process validations and maintain validated processes.
• Oversee CAPA system and drive root cause investigations.
• Administer Customer Complaint Management System and close out actions.
• Drive trend analysis and lean/culture of continuous improvement.

Connaissances

QA leadership

ISO 13485

FDA 21 CFR 820

CAPA system

DOE

SPC

Metrology

Calibration

Lean Manufacturing

Six Sigma

Communication

Formation

Bachelor's Degree in Engineering

Master's Degree preferred

Outils

Validation protocols

Process validation

Audit management

Description du poste

Quality Manager – Medical Device Manufacturing

Technimark is a global manufacturing solutions provider serving many of the world's leading healthcare, consumer packaging, and specialty industrial companies, Technimark is committed to delivering innovative solutions that improve lives while maintaining the highest standards of quality, safety, and regulatory compliance.

We're seeking an experienced Quality Manager to lead our Quality Management System (QMS) within our Medical Device Manufacturing operations. This is an exciting opportunity for a quality leader who thrives in a highly regulated environment and is passionate about driving continuous improvement, customer satisfaction, and operational excellence.

Reporting to the Senior Quality Manager, this role will serve as a key member of the site leadership team, ensuring compliance with ISO 13485, FDA regulations, and customer requirements while championing a culture of quality throughout the organization.

Responsibilities and Duties

• Ensure the Quality Management System remains effective, compliant, and continuously improving. Including maintaining compliance with ISO 13485, FDA 21 CFR Part 820, customer requirements, and internal quality standards.
• Report key quality metrics and performance indicators to leadership and recommend improvement initiatives.
• Manage the site's Master Validation Plan and validation strategy.
• Lead new process validations and maintenance of existing validated processes.
• Develop and execute validation protocols, data collection plans, statistical analyses, and validation reports.
• Ensure compliance with applicable regulatory requirements and quality standards.
• Oversee and maintain an effective Corrective and Preventive Action (CAPA) system.
• Lead root cause investigations and implementation of corrective and preventive actions.
• Administer the Customer Complaint Management System, ensuring timely response, investigation, resolution, and effectiveness verification.
• Drive trend analysis activities that support proactive quality improvements and risk reduction.
• Champion Lean Manufacturing and Continuous Improvement initiatives throughout the facility.
• Review quality data and determine product acceptability.
• Lead nonconforming material investigations and disposition activities.
• Ensure internal and external audit findings are addressed effectively and on time.
• Lead, coach, mentor, and develop Quality Engineers, Quality Supervisors, and quality team members.
• Build culture of accountability, compliance, engagement, and continuous learning.
• Build strong relationships and effectively address customer concerns related to product quality, compliance, and performance.
• Support customer audits and regulatory inspections with confidence and professionalism.

Required Experience

• Bachelor's Degree in Engineering, Quality, Life Sciences, Manufacturing, or related field.
• 5-10 years of Quality experience with 3+ years in a management role
• 5+ years of experience in Medical Device Manufacturing.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Experience leading Quality Management Systems in a regulated manufacturing environment.
• Experience with validation planning, protocol development, execution, and reporting.
• Knowledge of quality methodologies including:
• Statistical Process Control (SPC)
• Inspection Systems
• Metrology
• Instrument Calibration
• Design of Experiments (DOE)
• CAPA Systems
• Strong leadership, communication, and team development skills.

Preferred Experience

• Master's Degree in Engineering, Quality, or related discipline.
• ASQ certifications (CQE, CQM/OE, CMQ/OE, or equivalent).
• Experience in injection molding, medical device packaging, or high-volume regulated manufacturing.
• Lean Manufacturing and Six Sigma experience.
• Experience supporting FDA inspections and customer audits.

At Technimark, we're investing in advanced manufacturing technologies, and the people need to power our continued growth.

Technimark is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or protected veteran status.