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About the Role

The Quality Manager serves as the designated Quality Management Representative (QMR) for all aspects of the Quality System within a chemical mixing/medical device manufacturing operation. This role is responsible for planning, directing, and executing quality assurance, quality engineering, supplier quality, and quality control programs. The position ensures the development, application, and maintenance of quality standards, drives continuous improvement, and oversees the implementation and maintenance of an effective and compliant Quality System.

Responsibilities

• Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third-party audits and inspections, and organizing/conducting periodic Management Reviews of the Quality System.
• Carry out leadership responsibilities including interviewing, hiring, developing, training, planning, assigning, directing work, appraising performance, rewarding, coaching, addressing complaints, and resolving problems.
• Ensure all required investigations (e.g., complaints, NCs) are robust, thorough, and completed in a timely manner.
• Champion and lead continuous improvement, VIP, and standard work efforts.
• Chair the site’s Corrective Action Board (CAB) and drive the CAPA program by ensuring opportunities are well documented, timelines are adhered to, and status is reported to management.
• Oversee activities associated with calibration of Inspection, Measure, and Test Equipment (IM&TE), including standards, recall, review/approval of records, and out-of-tolerance investigations.
• Lead, maintain, and create efficiencies in the Quality Management System to fulfill domestic and international quality system requirements (e.g., FDA’s QMSR, ISO 13485, and other international standards).
• Host FDA/ISO and other regulatory agencies or customers for audits.
• Support product integrations associated with acquisitions and new product development.
• Ensure the effective maintenance of Device History Records and other quality documents.
• Manage the internal audit program, including training internal auditors, creating and maintaining internal audit schedules, and assuring internal audits are performed and completed according to the approved schedule.
• Monitor the health and well-being of the QMS through quality trending, analytics, and established KPIs.

Requirements

• Bachelor’s Degree in Engineering or a related technical discipline such as Chemistry or Biology.
• A minimum of 5-8 years of quality assurance experience in a medical device, pharmaceutical, or regulated manufacturing environment.
• A minimum of 1-3 years’ experience managing quality team members.
• Experience in chemical mixing, liquid formulation, or filling operations preferred.
• Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels.
• Ability to make effective decisions and maintain effectiveness under changing circumstances and priorities.
• Teamwork, communication, and positive attitude required to support the manufacturing environment.
• Extensive experience in problem-solving – able to perform root cause analysis and implement effective corrective actions.
• Able to effectively manage and complete multiple projects simultaneously.
• Excellent computer skills including but not limited to Microsoft Office Suite.
• Knowledge of quality systems including the quality manual, quality policy, and applicable procedures and work instructions.
• Ability to support the establishment, implementation, and maintenance of the quality system in accordance with FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.

Skills

• Leadership
• Team orientation
• Communication
• Problem-solving
• Root cause analysis
• Corrective actions
• Project management
• Microsoft Office Suite
• Quality systems management
• FDA Quality Management System Regulation
• ISO 13485
• European Union Medical Device Directives

Location

• Manufacturing facility

Work Type

• Full-time

Experience Level

• 5-8 years quality assurance experience
• 1-3 years management experience

Education Level

• Bachelor’s Degree in Engineering or related technical discipline
• Industry or discipline specific certification a plus (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc)

About the Company

• At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day.
• This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world.
• We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

Equal Opportunity

• We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.