Senior Director Quality Assurance

Role: Sr. Director, Quality Assurance

Location: Newark, CA

Type: Contract to hire or FTE

Job Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development, engineering builds, clinical builds, and transfer to manufacturing.

Responsibilities

• Provide project teams with the guidance necessary to maintain a high level of QMS compliance
• Ensure that project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed
• Ensure that project quality activities are efficient and effective and performed in a proactive manner
• Oversee the generation and maintenance of quality records that are consistent with QMS
• Ensure that project records are maintained in a state of readiness for external audits and regulatory inspections
• Maintain and regularly update library of applicable technical, quality, and risk management standards
• Maintain ISO 13485 certification, including managing internal audits
• Develop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to quality management systems
• Support QMS related training and professional development for scientific and technical staff
• Own the Quarterly Management Review process, managing and reporting project and operational quality metrics to management
• Provide input to quality-related strategic planning to meet short and long term business goals
• Provide management with objective evaluation of overall quality performance and guidance for implementation of improvements
• Actively participate in developing and deploying effective continuous improvement of quality management processes
• Serve as the QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary
• Manage Document Control function

Education, Experience, and Skills

• Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred
• ASQ and RAPS Certifications are a plus (e.g., Quality Engineer, Certified Quality Manager)
• ISO 13485 – Lead Assessor Certification preferred
• Knowledge and experience with advanced quality systems concepts
• In-depth knowledge of current regulatory expectations, quality and compliance processes, operations and strategy
• Demonstrated knowledge of interpretation and application of QSR, EU MDR, ISO 13485, and other applicable regulations and standards
• Minimum three (3) years of active senior quality management and leadership experience; and minimum ten (10) years related experience in an FDA regulated environment
• Experience in design, manufacturing, or technical support for medical devices or other technically complex or regulated products
• Working knowledge of engineering design and build practices
• Working knowledge of basic assembly and manufacturing processes
• Progressive QA/QC leadership experience, including "hands-on” detailed quality systems development and experience managing implementation of quality functions
• Current knowledge of applicable quality and regulatory requirements and trends including risk-based compliance requirements
• Active participation or thought leadership through ASQ or similar professional organizations addressing quality systems practices
• Demonstrated expertise in interpretation and pragmatic application of quality standards

Desired skills:

• Strong technical and conceptual aptitude in quality systems coupled with "out of the box” strategic thinking
• Strong leadership ability and superior interpersonal and communication skills championing the overall mission of quality
• Ability to take initiative in applying innovative approaches to quality solutions in a fast paced and highly varied environment
• Ability to provide alternatives including exploring new information and external insights without compromising compliance
• Demonstrated ability to influence areas not under direct control and effectively communicate goals and objectives
• Ability to work in a matrix environment and build relationships based on confidence rather than authority
• Capability to build alignment amidst diverse perspectives ranging from research & development to engineering to manufacturing
• Strong planning and implementation capabilities
• Ability to make and act on sound fact-based decisions while balancing time-constraints, quality, and risk
• Comfortable with electronic documentation/records systems and strong general office computing skills, including experience with creating Microsoft Office templates

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.