Job Description

POSITION PURPOSE:

The Director of Quality Assurance will oversee the quality systems and standards for the organization, ensuring that all products meet regulatory requirements and internal specifications. This leadership role is critical to maintaining our commitment to excellence and compliance throughout the product lifecycle. This position aims to monitor and improve a quality management system, maintaining compliance with established standards and agency guidelines.

SUMMARY OF RESPONSIBILITIES:

Act as a Management Representative, as needed. Implement the necessary changes in the quality system for improvements and maintain compliance with established standards. Maintain quality assurance programs, policies, processes, procedures, and controls, ensuring that the performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements and business process improvement initiatives. Responsible for providing adequate support for creating and preparing documentation that is required by the regulatory department for global registration submissions and approvals to introduce new products in the US, EU, Canada, Australia, and other jurisdictions for Class I, II devices, NHPs, and drugs.

KEY RESPONSIBILITIES:

• Act as a Management Representative, as necessary.
• Report to VP of QA/RA and Mfg.
• Be responsible for the performance of the quality management system and address any need for improvement.
• Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
• Oversee generation and review of documents used in good manufacturing practices and monitor audits of production and quality control areas. Provide expertise and guidance in interpreting governmental Quality regulations, agency guidelines, and internal policies to ensure compliance and effectiveness.
• Manage document control and oversee related quality systems such as training and other electronic quality systems to ensure effectiveness.
• Participate with peers in formulating overall direction, processes, systems, and talent development for the QA organizations.
• Provide adequate support for document preparation for global regulatory submissions, including but not limited to the FDA 510(k), technical documentation for medical devices and dossiers for drugs, Canadian medical device, NHP and drug license applications, internal "Letters to File", etc.
• Assess device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
• Review and sign off on product and manufacturing changes for compliance with applicable regulations.
• Review, assess, and approve product documents, including but not limited to the design and manufacturing changes and labeling.
• Review and approve test protocols to support regulatory submissions.
• Oversee Risk Management and provide input in design verification, design validation and shelf-life studies.
• Provide technical guidance and training / mentoring to other QA employees and cross-functional teams.
• Develop and implement departmental goals, policies, and procedures.
• Monitor industry trends and regulatory changes to ensure that company practices remain compliant and competitive.
• Other duties as assigned.

KNOWLEDGE / EDUCATION

• Bachelor's degree in science minimum. (Master’s degree in science preferred).
• Knowledge of the FDA medical device and drug regulations, guidance, and import / exports requirements.
• Knowledge of European Medical Regulations (MDR).
• Knowledge of medical device labeling and promotional requirements.
• Strong understanding of the quality system regulations.
• Thorough knowledge of product development process, design control and Quality System.
• Strong technical knowledge of medical devices and OTC Drug products.
• Strong technical understanding of relevant procedures, practices, and medical terminology.

JOB EXPERIENCE

• At least 10 years of experience in the medical industry as a Director or Senior Manager of Quality Assurance.
• At least 10 years of experience managing/leading a team.
• Demonstrated success in Quality Management.
• Demonstrated management skills and experience.
• Experience developing a team and individuals
• Knowledge of or experience in Risk management.
• Knowledge of QS regulations preferred.
• Statistical analysis and problem-solving abilities are strongly preferred.
• Demonstrate extensive experience with the FDA, ISO 13485, and Notified Body inspections

SKILLS / COMPETENCIES

• Proficient in timely review of technical and clinical data.
• Proficient in FDA and international regulations (e.g., EU and Canada)
• Technical knowledge of medical devices (class I and II) and drugs.
• Ability to write clear, concise, and well-thought-out technical documents.
• Good presentation skills.
• Strong communication skills
• Ability to perform well in stressful or time-sensitive situations
• Able to manage complex problems/projects by exercising independent decision-making and analytical thinking skills, with minimal supervision
• Computer skills: MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, graphics presentation etc.
• Strong leadership, organizational, interpersonal, and influencing skills
• Strong written and oral communication skills
• Detail-oriented and self-motivated.
• Ability to work well with team members and clients
• Ability to exercise judgment in selecting innovative, practical methods to achieve problem resolution.
• Excellent negotiation skills.
• Ability to work under minimal supervision and independently.
• Must be able to deliver high-quality work in a tight-timeline-driven environment.
• Strong leadership, interpersonal and influencing skills.
• Ability to be flexible and adjust to changing circumstances.
• This is a full-time, on-site role based in our Santa Rosa Headquarters. Must be available to work 5 days per week, one Saturday per month and as needed per business requirements.

BENEFITS

• Competitive salary bonus potential
• Relocation support as needed
• Health benefits including medical, dental and vision coverage for
• employee and family
• 401(k) with 4% match
• 2 weeks paid vacation
• 6 paid holidays
• Sick days per California law

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