Quality Manager

Aspen Surgical; Hempfield Township (Westmoreland County); On-site; USD 110,000 - 160,000; Full time

Job summary

Aspen Surgical in the United States is seeking a Quality Manager to serve as the QMR for our chemical mixing and medical device manufacturing operations. You will lead QA, QE, supplier QA, and QC programs, shaping the quality system to meet regulatory standards and drive improvements.

The role requires directing cross-functional teams, ensuring timely investigations, CAPA leadership, and maintaining FDA/ISO compliance. Join a team committed to safety and quality across the product lifecycle.

Qualifications

• Bachelor’s Degree in Engineering or a related technical field such as Chemistry or Biology.
• 5–8 years of quality assurance experience in a medical device, pharmaceutical, or regulated manufacturing environment.
• 1–3 years’ experience managing quality team members.
• Industry or discipline specific certification (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc) is a plus.
• Experience in chemical mixing, liquid formulation, or filling operations preferred.
• Strong interpersonal skills: leadership, team orientation, communication at all levels.
• Extensive experience in problem solving – root cause analysis and corrective actions.

Responsibilities

• Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third party audits and inspections, and managing periodic Management Reviews of the Quality System.
• Lead and develop the quality team, including hiring, coaching, and performance reviews.
• Ensure investigations (e.g., complaints, NCs) are robust and timely.
• Champion continuous improvement, VIP, and standard work initiatives.
• Chair the site’s CAB and drive the CAPA program with documented timelines and routine status reporting.
• Oversee calibration of Inspection, Measurement, and Test Equipment (IMTE) and review related records.
• Lead and maintain the Quality Management System to meet FDA QMSR, ISO 13485, and other international standards.
• Support product integrations with acquisitions and new product development.
• Maintain Device History Records and other quality documents.
• Manage internal audit program including training internal auditors and scheduling audits.
• Monitor QMS health via trends, analytics, and KPIs.

Skills

Leadership

Team management

Communication

Problem solving

Project management

Quality systems

Education

Bachelor’s degree in Engineering or related field (Chemistry/Biology)

Job description

About Aspen

We love what we do! 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.

Summary

The Quality Manager serves as the designated Quality Management Representative (QMR) for all aspects of the Quality System within our chemical mixing / medical device manufacturing operation. This role has responsibility for planning, directing, and executing activities of our quality assurance, quality engineering, supplier quality, and quality control programs including strategic leadership for related activities, assuring the development, application, and maintenance of quality standards for processes, materials, and products. This role is also responsible for the achievement of quality objectives and operational targets, corrective action, and the implementation and maintenance of an overall effective and compliant Quality System.

In This Position, You Will Have The Opportunity To

• Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third party audits and inspections, organizing and conducting periodic Management Reviews of the Quality System
• Carry out leadership responsibilities in accordance with the organization’s policies and applicable laws which includes interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems
• Ensure all required investigations (i.e. 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 on a routine basis
• 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 both 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, assuring internal audits are performed and completed according to approved schedule
• Monitor the health and well-being of the QMS through quality trending, analytics and established KPIs

What You Need To Succeed In This Position

• 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.
• Industry or discipline specific certification a plus (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc)
• 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, 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 to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.

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