Quality Manager- Medical Device Manufacturing

Job Description

Job Description

Quality Manager – Medical Device Manufacturing

Full-Time | Direct Hire

Bonus: 10% annual bonus eligibility
Schedule: Monday–Thursday | Four 10-hour shifts | Typically 6:00 AM–4:30 PM
Location: 100% Onsite –
Relocation Assistance: Available

Position Overview

We are seeking an experienced, hands-on Quality Manager to lead quality operations for a growing medical device manufacturing facility in Snoqualmie, Washington.

This position offers an opportunity to lead and improve the Quality Management System (QMS), develop a quality team, and play a critical role in manufacturing process validation, regulatory compliance, and new product introduction.

The ideal candidate brings strong leadership experience, a thorough understanding of ISO 13485 , and direct experience personally developing process documentation and executing IQ, OQ, and PQ validation activities .

This is a hands-on leadership position requiring both technical expertise and the ability to drive continuous improvement across manufacturing operations.

Key Responsibilities

• Lead, maintain, and continuously improve the facility's Quality Management System in accordance with ISO 13485.
• Personally develop and execute process validation and qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop validation protocols, technical reports, standard operating procedures, work instructions, and quality documentation.
• Lead quality investigations, root-cause analysis, corrective and preventive actions (CAPA), and process improvement initiatives.
• Partner with Manufacturing, Engineering, and Operations to troubleshoot quality issues and improve production processes.
• Oversee quality compliance, risk management, change control, and process documentation.
• Support supplier quality, customer quality requirements, and product specification reviews.
• Prepare for and participate in customer, internal, and regulatory audits.
• Support new product introduction (NPI), process improvements, and manufacturing expansion.
• Lead, mentor, and develop quality personnel while promoting a strong culture of accountability and continuous improvement.

Required Qualifications

Candidates must meet all four requirements:

1. Medical Device Manufacturing Experience: Direct experience working in a discrete medical device manufacturing environment. Pharmaceutical manufacturing experience alone does not satisfy this requirement.
2. ISO 13485 Expertise: Demonstrated experience implementing, maintaining, or improving quality management systems governed by ISO 13485.
3. Leadership Experience: Proven ability to lead, mentor, or develop quality teams and collaborate effectively with cross-functional departments.
4. Hands-On IQ/OQ/PQ Validation Experience: Extensive practical experience personally developing process documentation, writing validation protocols, and executing Installation Qualification, Operational Qualification, and Performance Qualification activities.

Important: This position requires direct, hands-on validation experience. Candidates whose experience is limited to overseeing validation teams, reviewing documentation, or managing validation programs without personally executing the technical work will not meet the requirements.

Preferred Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Chemistry, Biology, or a related technical discipline.
• Experience with ISO 9001 and ISO 14971 risk management.
• Knowledge of FDA medical device quality and regulatory requirements.
• Experience with quality system improvements and change management.
• Lead Auditor certification.
• Lean Manufacturing, Six Sigma, or Kaizen experience.
• Knowledge of cleanroom operations, contamination control, or ISO 14644.
• Experience supporting new product introduction and manufacturing growth.

Compensation & Benefits

• Competitive annual base salary of $115,000–$150,000 , based on qualifications and experience.
• Eligibility for a 10% annual performance bonus.
• Relocation assistance available for qualified candidates.
• Approximately three weeks of paid time off.
• Four-day workweek, Monday through Thursday.
• Full-time, direct-hire opportunity with long-term career growth.

Apply Today

If you are a Quality Manager with direct medical device manufacturing experience, ISO 13485 expertise, strong leadership skills, and hands-on IQ/OQ/PQ validation experience, we encourage you to apply.

Join a growing manufacturing organization where your technical expertise and leadership will directly influence product quality, manufacturing performance, and continued business growth.

Come join the Workforce of the Future with ERS. We have been placing qualified candidates in the at some of the most successful companies for 54 years.

Become a part of our team!

Company Description

Come join the Workforce of the Future with ERS. We have been placing qualified candidates in the at some of the most successful companies for 54 years. \r\n\r\nBecome a part of our team!