Senior Quality Engineer

Agendia; California; On-site; USD 120,000 - 160,000; Full time

Job summary

Agendia is seeking a QA/RA specialist to oversee quality engineering activities and ensure compliance with FDA/ISO requirements in product development and manufacturing.

You will drive continuous improvement across design control, risk management, supplier quality, and post-market surveillance, collaborating with Laboratory Operations, Product Development, and external regulators. Candidates should have a strong background in medical devices and regulatory affairs.

Qualifications

• Bachelor’s degree in a technical field; quality focus preferred.
• ASQ CQE or equivalent certification required; auditor certification preferred.
• Experience in regulatory affairs or quality management systems for medical devices.

Responsibilities

• Implement quality engineering tools to drive process development.
• Ensure compliance with FDA, ISO 13485, IVDR, and related standards.
• Lead investigations, CAPA, and continuous improvement.
• Participate in Design Control and Risk Management activities.
• Coordinate Post-Market Surveillance and supplier quality efforts.
• Manage quality agreements with vendors and verification protocols.
• Support audits and management reviews across functions.

Skills

Quality tools

Statistics

Sampling plans

Reliability engineering

Software engineering

Design assurance

Regulatory compliance

Process engineering

Education

Bachelor's Degree in Life Science/Engineering

ASQ CQE/Quality Engineer

ASQ Auditor or Lead Auditor

Tools

MS Office

Statistical software

Job description

Ensure products meet specifications and are developed and manufactured with highest product quality and meet all applicable product quality, design and manufacturing process requirements. Provide support in areas of process engineering, product quality assurance to drive continuous process and product improvements.

POSITION WITHIN THE ORGANIZATION

• Reports to Senior Director, QA/RA
• Cooperates with all departments across the organization
• Organizes activities within the QA/RA Department
• Meetings with Internal and External Stakeholders - Amsterdam site, vendors, suppliers
• Project groups

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Implementation of quality engineering tools throughout the organization to drive methodical process development. Utilize quality tools such as lean principles, statistics, sampling plans, reliability engineering, software engineering and design assurance techniques.
• Conduct engineering activities in compliance with FDA Regulations, ISO 13485, ISO 14971, IVDR, and other national and international quality and regulatory requirements and standards.
• Conduct investigations and provide corrective and preventive actions based on sound engineering analysis and review. Provide effective and practical solutions that will drive continuous and measurable improvements.
• Participate in Design Control activities, including Risk Management.
• Coordinate Post-Market Surveillance activities.
• Author and manage Quality Agreements with mission-critical vendors, establishing rigorous incoming inspection criteria (including verification vs. vendor CoA protocols).
• Analyze data, interpret results and write protocols and reports required to document results from assigned tasks.
• Support the product quality activities through the application of engineering tools and disseminating knowledge throughout the organization.
• Support Internal, External and Supplier Audits.
• Support Quality Metrics and Management Review activities.
• Collaborate internal functions including supply chain, operations to define, develop, and implement continuous improvement with suppliers in the areas of quality, delivery, process optimization, and total cost management. Provide technical assistance to suppliers and other resources performing training and qualification/validation testing.
• Collaborate with Laboratory Operations, Product Development and other departments to ensure quality processes are implemented. Including product design testing, process testing, equipment/software qualification, validation, risk management activities
• Collaborate with the procurement department in supplier optimization efforts. Tasks include the identification of key suppliers based on supplier competencies/qualifications, quality systems and performance/track record.
• Serve as back-up Person Responsible for Regulatory Compliance (PRRC)
• Perform other duties as assigned.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

QA/RA SPECIFIC RESPONSIBILITIES

• Person Responsible for Regulatory Compliance - PRRC
• Management Representative
• Back-up Management Representative

Product release under the QMS

• Ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Ensuring the reporting obligations referred to in Articles 82 to 86, Regulation 2017/746 are fulfilled. This includes serious incidents and field safety corrective actions, trend reporting, and analysis of vigilance data.
• In the case of performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risk for the subjects, ensuring the statement referred to in section 4.1 of Annex XIV, Regulation 2017/746 is issued.

KEY CONTACTS

Internal

• Laboratory Operations, Product Development, Marketing, Supply Chain Management

External

• External Suppliers, Notified Body, Regulators: FDA, CLIA/CAP, NYSDOH

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

• Bachelor's Degree or above, preferably with a concentration in Quality, Life Science, Biology, Pharmacy, Biomedical Engineering, Statistics, or related technical discipline
• ASQ Certified Quality Engineer, Reliability or Software Engineer required
• ASQ Certified Quality Auditor or other Lead Auditor certification preferred

EXPERIENCE

• At least 3 years' expertise in Regulatory Affairs or Quality Management Systems for medical devices (In Vitro Diagnostic, Class II or Class III medical devices preferred)

Specific Knowledge Required

Knowledge: Comprehension of a body of information acquired by experience or study.

Skill: A present, observable competence to perform a learned activity.

Ability: Competence to perform an observable behavior.

• Knowledge of ISO 13485, ISO 14971, IVDR and 21 CFR 820
• Knowledge of CAP/CLIA Requirements preferred
• Knowledge of Analytical/Statistical Principles
• Customer Focused Quality Process Improvement
• Knowledge of Quality System standards
• Knowledge of Root Cause Investigation tools
• Project Management Skills
• Technical Presentation Skills
• Capable of interacting with all levels of management, employees, supplier and clients
• Familiarity with Supplier Quality and Contract Manufacturing Activities

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

Examples:

• Ability to multi-task
• Computer Proficiency, such as MS Office
• Critical Thinking
• Strong problem-solving skills
• Quality Engineering statistical tools
• Project management
• Effective interpersonal skills
• Result - and customer orientation
• Initiative
• Flexibility
• PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/
• Employees must not be classified as an excluded individual who is prohibited from participation in any Federal health care program.

WORKING ENVIRONMENT

Established ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

• Specific vision abilities include close vision, distance vision, and color vision
• Work in a Lab Environment as needed
• Must be able to read and understand scientific and complex directions
• Applicants must be currently authorized to work in the United States on a full-time basis without the need for current or future sponsorship