Senior Quality Assurance Specialist

Connexis Search Group; Irvine (CA); Sur place; USD 120 000 - 140 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid time off

Holidays

Cutting-edge diagnostic technology

Career growth opportunities

Impact on global infectious disease

Résumé du poste

Connexis Search Group in Irvine, CA seeks a Senior Quality Assurance Specialist to lead QMS improvements aligning with FDA 21 CFR Part 820 and ISO 13485. The role works cross-functionally to ensure product quality and drive continuous improvement in a regulated environment.

On-site requirement at the Irvine facility with strong data-driven decision-making. You will drive internal audits, CAPA, supplier quality, and lifecycle quality across R&D, Manufacturing, Regulatory, and Commercial teams,

Qualifications

• 3–5 years of quality experience in medical device/IVD industry.
• Master's degree: 2–3 years; PhD: 1–2 years experience.
• Good knowledge of FDA QMSR, ISO 13485:2016, and ISO 14971:2019.
• Experience with supplier management and internal/external audits.
• Hands-on experience with eQMS tools (e.g., Agile, Greenlight Guru, IQS, MasterControl, Veeva Vault).
• On-site availability at Irvine, CA facility (no remote option).

Responsabilités

• Lead internal audit program and CAPA program management.
• Develop and continuously improve quality system processes to meet regulatory and business requirements.
• Support reporting of quality performance, compliance status, risks, and trends.
• Support external audits and inspections by regulatory bodies.
• Oversee supplier quality management, qualification, auditing, and KPIs.
• Lead SCAR processes and drive root cause investigations and systemic CAPA.
• Oversee design controls, V&V, and lifecycle management for product development and regulatory submissions.
• Collaborate with R&D, Manufacturing, Regulatory, and Commercial teams to integrate quality across product realization.

Connaissances

Quality Assurance

Internal Audits

CAPA Management

Data Analysis

Statistical Methods

Regulatory Knowledge

Cross-functional Collaboration

Communication Skills

On-site Availability

Formation

Bachelor's degree in Life Sciences

Master's degree in related field

PhD in related field

Outils

Agile eQMS

Greenlight Guru

IQS

MasterControl

Veeva Vault

Description du poste

My client is seeking a highly motivated and detail-oriented Senior Quality Assurance Specialist to support and enhance their Quality Management System (QMS) in compliance with FDA 21 CFR Part 820 and ISO 13485:2016, and other applicable requirements for both IVD and RUO products. This role serves as a subject matter expert of Quality Management System, working cross-functionally with R&D, Manufacturing/Operations, Regulatory Affairs, and Customer Service, Marketing to ensure product quality and drive continuous improvement. The ideal candidate brings a solid understanding of quality management principles, and proven experience applying data-driven decision-making in a regulated environment.

Key Responsibilities include:

Quality Management System

• Lead internal audit program, lead and manage CAPA program.
• Develop, maintain, and continuously improve quality system processes and procedures to meet regulatory and business requirements, ensure adherence to global regulatory requirements (ISO 13485, ISO 14971, FDA 21 CFR 820/QMSR, MDSAP).
• Support quality leadership on reporting quality system performance, compliance status, risks, trends, and improvement opportunities
• Support external audits and inspections by regulatory agencies and notified bodies.

Supplier Quality Management

• Global Supplier Quality Management program owner, including supplier qualification, auditing, performance monitoring, and development.
• Drive supplier quality improvements using scorecards, KPIs, and structured improvement initiatives.
• Lead SCAR processes and ensure timely and effective resolution of supplier issues.
• Lead complex root cause investigations and drive effective CAPA implementation with systemic improvements.

Product Life Cycle Quality

• Oversee quality activities for new product development and design changes, ensuring compliance with design controls, risk management, V&V, and support regulatory submission as needed.
• May serve as quality approver at design reviews and tollgates, ensuring alignment with FDA, ISO 13485, and global regulatory requirements.
• Provide oversight for design transfer, process validation, and lifecycle management to ensure sustained product performance and compliance.
• Partner with R&D, Manufacturing, Regulatory, and Commercial teams to integrate quality into all stages of product realization and product life cycle management.

Additional Responsibilities may include:

Data Analysis and Statistical Methods

• Analyze quality data to identify trends and opportunities for improvement.
• Apply Statistical Process Controls and other statistical tools to monitor process capability and product quality.
• Update quality dashboards, reports, and management review presentations, as required.

Required Education and Experience

• Bachelor’s degree in molecular biology, Biochemistry, Microbiology, Biotechnology, Biomedical Engineering, Chemistry, or related life science field with minimal of 3-5 years of quality experience in medical device/IVD industry.
• Master’s degree with 2-3 years of Quality Assurance experience in a medical device/IVD industry; or Ph.D. degree with 1-2 years of relevant industry experience.
• Good knowledge of FDA QMSR, ISO 13485:2016, and ISO 14971:2019.
• Experience in Supplier Management, Internal and external audit.
• Hands-on experience with eQMS such as Agile, Greenlight Guru, IQS, Master Control, Veeva Vault, etc.
• Self-motivated and detail-oriented, with strong analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills, with the ability to work effectively in a collaborative, cross-functional team environment.
• On-site availability at the Irvine, CA facility (no remote/hybrid option).

Preferred Education and Experience

• ASQ certifications (CQA, CQE, CSQP) or ISO auditor certifications are strongly preferred.
• Knowledge of PCR assay, experience of molecular diagnostics assay.
• Hands-on experience in design control and risk management.
• Strong statistical analysis skills (SPC, capability analysis, sampling plans).

Physical Requirements & Work Environment

• Ability to work on-site during standard business hours with occasional extended hours.
• Ability to sit for prolonged periods and use a computer.
• Occasional standing, walking, bending, and lifting to 25 lbs.
• Visual acuity to read documentation and inspect materials.
• Occasional travel (<10%) for audits, training, or conferences.

What We Offer

• $120k - $140k salary commensurate with experience.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and holidays.
• Collaborative environment with exposure to cutting-edge diagnostic technology.
• Strong opportunities for career growth within a rapidly expanding company.
• Chance to make a meaningful impact on global infectious disease diagnostics.