Quality Manager

Aspen Surgical; New York, Northern (NY, KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Aspen Surgical in New York seeks a Quality Manager to act as the Quality Management Representative for the facility. You will plan, direct, and execute activities across quality assurance, quality engineering, supplier quality, and quality control to maintain a compliant Quality System for chemical mixing and medical device manufacturing.

Lead audits, CAPA, calibration oversight, and continuous improvement initiatives while guiding a team of QA professionals.

Qualifications

• Bachelor’s degree in Engineering or related technical field required.
• 5–8 years of quality assurance experience in a medical device, pharmaceutical, or regulated environment.
• 1–3 years’ experience managing quality team members.
• Certification such as CQE, CQA, CMQ/OE, Lean or Six Sigma is a plus.
• Experience in chemical mixing, liquid formulation or filling operations preferred.
• Strong leadership, communication and problem-solving abilities.
• Ability to manage multiple projects and adapt to changing priorities.
• Proficiency with Microsoft Office and quality systems documentation.
• Knowledge of FDA QMSR, ISO 13485 and EU Medical Device Directives.

Responsibilities

• Serve as the Quality Management Representative (QMR) for the facility and coordinate audits.
• Lead interviews, hiring, training, and employee development; manage performance.
• Ensure investigations (complaints, NCs) are thorough and timely.
• Champion continuous improvement, VIP, and standard work efforts.
• Chair the CAPA program and report status to management regularly.
• Oversee calibration of IM&TE equipment and review records.
• Lead and maintain the quality management system for domestic and international standards.
• Host FDA/ISO/regulatory audits and customer inspections.
• Support product integrations and new product development.
• Maintain Device History Records and quality documents.
• Manage internal audit programs and KPI monitoring.

Skills

Leadership

Quality assurance

Root cause analysis

Project management

Communication

Teamwork

Decision making

Problem solving

Adaptability

Interpersonal skills

Education

Bachelor’s Degree in Engineering or related technical discipline

CQE / CMQ/OE / Six Sigma certification a plus

Tools

Microsoft Office Suite

Quality management tools

Job description

Posted Tuesday, August 18, 2026 at 4:00 AM

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.

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.