Manager of Quality
Accordance Search Group, Seattle, WA, United States
The
Quality Manager, R&D & Operations QA/RA
a critical leadership role within a scaling, high-growth organization developing innovative medical devices to improve sample collection and integrity for in-vitro diagnostic (IVD) testing. This role combines hands‑on quality system ownership with people leadership, including coaching, mentoring, and development of direct reports.
Based onsite at the downtown Seattle corporate headquarters, this position partners closely with executive leadership and cross‑functional teams to scale a robust, compliant Quality Management System (QMS) aligned with ISO 13485, MDSAP, and EU MDR.
Position Description
The Quality Manager, R&D & Operations QA/RA is responsible for the effectiveness, compliance, and continuous improvement of the organization’s QMS while leading a Quality team. The role serves as the Quality and Regulatory subject matter expert, management representative and eQMS owner, ensuring regulatory readiness as the company scales products, operations, and partnerships.
This leader will guide all aspects of the Quality and Regulatory system while fostering a culture of quality, accountability, and continuous improvement throughout the organization.
Key Responsibilities
Lead, coach, and mentor Quality team members, providing clear expectations, performance feedback, and development opportunities
Define, implement, scale, and continuously improve the QMS in compliance with ISO 13485, FDA QSR (21 CFR 820), and applicable IVD regulations
Serve as Quality Systems SME and primary point of contact for ISO 13485, MDSAP, and EU MDR
Author, review, approve, and maintain SOPs, work instructions, and quality records
Oversee document control, document templates, and change control processes
Manage and trend QMS events including deviations, nonconformances, CAPAs, complaints, and system‑related design controls
Ensure effective root cause analysis and timely closure of quality events
Develop and execute quality system training strategies in partnership with functional leaders
Ensure timely training completion and documentation in compliance with FDA and ISO requirements
Support and lead internal audits, supplier audits, and external audits including ISO 13485 certification audits and FDA inspections
Drive audit readiness activities, inspection response coordination, and remediation efforts
Support supplier quality activities and oversight of Contract Manufacturing Organizations (CMOs)
Champion continuous improvement initiatives to enhance QMS efficiency and scalability
Perform other duties as assigned
Physical and Work Requirements
Ability to sit and/or stand and work at a computer for extended periods
Ability to use a keyboard, mouse, and standard office equipment
Ability to lift up to 10–20 lbs occasionally
Ability to communicate clearly and professionally in person and by phone
Ability to travel to Contract Manufacturing and Supplier sites as needed (est 15-20%)
Experience and Qualifications
Bachelor’s degree (BA/BS) in science, engineering, or related discipline, or equivalent combination of education and experience
6–9 years of progressive experience in Quality Systems within a regulated medical device or IVD environment
Demonstrated experience scaling Quality Systems within a growing or transitioning organization
Proven experience leading, coaching, and mentoring direct reports
Strong hands‑on experience maintaining ISO 13485–certified Quality Management Systems
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820) with experience supporting FDA inspections
Familiarity with ISO 14971 (risk management), EU MDR, and global regulatory requirements
Experience ensuring alignment with applicable cGMP, GDocP, and QMS regulatory guidance
Experience managing deviations, CAPAs, change controls, complaints, and audit findings
Experience supporting CMOs and supplier quality oversight
Proficiency with Microsoft Office and GMP‑compliant electronic systems (e.g., eQMS platforms, Salesforce or similar)
Ability to prioritize, meet deadlines, and adapt in a fast‑paced, scaling environment
Strong written and verbal communication skills
Demonstrated leadership, accountability, and decision‑making skills
Ability to influence without authority and effectively resolve challenges with professionalism and diplomacy
Preferred Certifications
ASQ Certified Quality Auditor (CQA)
Regulatory Affairs Certification (RAC)
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Quality Manager, R&D & Operations QA/RA
a critical leadership role within a scaling, high-growth organization developing innovative medical devices to improve sample collection and integrity for in-vitro diagnostic (IVD) testing. This role combines hands‑on quality system ownership with people leadership, including coaching, mentoring, and development of direct reports.
Based onsite at the downtown Seattle corporate headquarters, this position partners closely with executive leadership and cross‑functional teams to scale a robust, compliant Quality Management System (QMS) aligned with ISO 13485, MDSAP, and EU MDR.
Position Description
The Quality Manager, R&D & Operations QA/RA is responsible for the effectiveness, compliance, and continuous improvement of the organization’s QMS while leading a Quality team. The role serves as the Quality and Regulatory subject matter expert, management representative and eQMS owner, ensuring regulatory readiness as the company scales products, operations, and partnerships.
This leader will guide all aspects of the Quality and Regulatory system while fostering a culture of quality, accountability, and continuous improvement throughout the organization.
Key Responsibilities
Lead, coach, and mentor Quality team members, providing clear expectations, performance feedback, and development opportunities
Define, implement, scale, and continuously improve the QMS in compliance with ISO 13485, FDA QSR (21 CFR 820), and applicable IVD regulations
Serve as Quality Systems SME and primary point of contact for ISO 13485, MDSAP, and EU MDR
Author, review, approve, and maintain SOPs, work instructions, and quality records
Oversee document control, document templates, and change control processes
Manage and trend QMS events including deviations, nonconformances, CAPAs, complaints, and system‑related design controls
Ensure effective root cause analysis and timely closure of quality events
Develop and execute quality system training strategies in partnership with functional leaders
Ensure timely training completion and documentation in compliance with FDA and ISO requirements
Support and lead internal audits, supplier audits, and external audits including ISO 13485 certification audits and FDA inspections
Drive audit readiness activities, inspection response coordination, and remediation efforts
Support supplier quality activities and oversight of Contract Manufacturing Organizations (CMOs)
Champion continuous improvement initiatives to enhance QMS efficiency and scalability
Perform other duties as assigned
Physical and Work Requirements
Ability to sit and/or stand and work at a computer for extended periods
Ability to use a keyboard, mouse, and standard office equipment
Ability to lift up to 10–20 lbs occasionally
Ability to communicate clearly and professionally in person and by phone
Ability to travel to Contract Manufacturing and Supplier sites as needed (est 15-20%)
Experience and Qualifications
Bachelor’s degree (BA/BS) in science, engineering, or related discipline, or equivalent combination of education and experience
6–9 years of progressive experience in Quality Systems within a regulated medical device or IVD environment
Demonstrated experience scaling Quality Systems within a growing or transitioning organization
Proven experience leading, coaching, and mentoring direct reports
Strong hands‑on experience maintaining ISO 13485–certified Quality Management Systems
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820) with experience supporting FDA inspections
Familiarity with ISO 14971 (risk management), EU MDR, and global regulatory requirements
Experience ensuring alignment with applicable cGMP, GDocP, and QMS regulatory guidance
Experience managing deviations, CAPAs, change controls, complaints, and audit findings
Experience supporting CMOs and supplier quality oversight
Proficiency with Microsoft Office and GMP‑compliant electronic systems (e.g., eQMS platforms, Salesforce or similar)
Ability to prioritize, meet deadlines, and adapt in a fast‑paced, scaling environment
Strong written and verbal communication skills
Demonstrated leadership, accountability, and decision‑making skills
Ability to influence without authority and effectively resolve challenges with professionalism and diplomacy
Preferred Certifications
ASQ Certified Quality Auditor (CQA)
Regulatory Affairs Certification (RAC)
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