Director of Quality Operations

Job 2750 - Director of Quality Operations – Contract to Permanent opportunity located near San Francisco, California

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative and corrective action and create a roadmap for ongoing future improvement by identifying, integrating and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Onsite

Background

The client is a rapidly growing In Vitro Diagnostic device company that develops biomarker detection technologies and reagents, with approximately 250 employees located in the Bay Area of California. The company currently provides Research Use Only (RUO) solutions including in-house development and manufacturing of assay components. The company is leveraging its technology platform to develop clinically validated IVD products intended to initially be commercially available in the United States.

The company has established an ISO 13485 certified Quality Management System (QMS). However, a company program is underway to enhance the QMS, validate and qualify tools and equipment, and complete process validation to meet IVD regulatory requirements.

The client is seeking a contract resource to serve in the Director of Quality Operations role until permanent resource is hired. This resource will be responsible for In Vitro Device (IVD) manufacturing quality support.

Role Overview

We are seeking an experienced and detail-oriented Director of Quality Operations to manage and continuously improve the quality aspects of the manufacturing process to ensure compliance with global medical device regulations including 21 CFR Part 820 and ISO 13485. Future compliance with EU IVDR may also be required.

This role is pivotal in ensuring robust processes are in place to support design transfer, manufacturing, distribution, and post-market activities across the organization.

Key Responsibilities

• Own and manage the company’s quality operations processes, including production and process controls, ensuring compliance with 21 CFR Part 820, ISO 13485.
• Partner with Manufacturing and Engineering to ensure appropriate process controls, validation activities, and quality oversight are implemented for production processes.
• Support internal audits and external audits (e.g., FDA, Notified Bodies), ensuring timely closure of findings and sustainable improvements.
• Maintain and continually improve QMS procedures, forms, templates, and records; oversee document control processes.
• Lead operations related Nonconformance and CAPAs including investigation, root cause analysis, effectiveness checks, and timely closure.
• Facilitate quality related training and ensure employee awareness and compliance with regulatory and procedural requirements.
• Support Regulatory Affairs with documentation and data for regulatory submissions, technical files, and certifications.
• Generate and analyze quality metrics and reports to identify trends and drive improvements.
• Collaborate with cross-functional teams to ensure quality integration across design, development, manufacturing, and post-market activities.
• Champion a culture of continuous improvement and compliance throughout the organization.
  
  

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Quality, or a related field.
• Minimum of 8-12 years of experience in operations quality management within the IVD or life sciences industry.
• Experience supporting manufacturing scale-up, design transfer, or establishment of quality operations in a regulated environment
• Strong knowledge of 21 CFR Part 820, ISO 13485 and related standards such as ISO 14971, ISO 9001, and IEC 62304.
• Demonstrated success in managing Nonconformances and CAPAs.
• Excellent analytical, problem-solving, and organizational skills with a detail-oriented mindset.
• Strong communication and interpersonal skills with the ability to interact across all levels of the organization.
• Demonstrated professional written and verbal communication.
• This role requires a hands-on approach with ownership of both process development and execution
  
  

Preferred Qualifications

• Experience with diagnostic medical device products.
• Experience with EU IVDR requirements.
• Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Certified ISO 13485 Lead Auditor preferred.
• Familiarity with software validation and quality requirements for QMS software tools.
• Lean Six Sigma Green or Black Belt certification is a plus.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice