Leader, Quality (San Diego)
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
The Director of Quality will lead and manage all day-to-day activities of the company's quality management program to ensure compliance with all federal and international regulations. This individual will provide strategic direction, oversight, and smooth execution of all quality functions within the organization. Develops, implements and maintains technical quality assurance and control systems and activities. This will be a hands on leadership position.
- Manages the internal audit function within the company to ensure compliance to applicable regulatory and corporate standards/requirements and ISO.
- Manages the CAPA program and performs root cause investigation, determines corrective action, and verifies effectiveness of such actions; investigates customer complaints, vendor, and internal nonconformance’s.
- Manage a compliant document control system and the company training program.
- Oversees quality engineering function, including activities for Process Validation (IQ/OQ/PQ), Equipment Qualification, Risk Analysis (PFMEA & DFMEA), Experimental Design (DOE) and Test Method Validation.
- Provides guidance and oversight for qualification and validation protocols for new equipment.
- Prepares and presents technical and program information to team members and management.
- Communicates significant issues or developments identified during quality assurance activities and recommends process improvements to departmental heads.
- Manages the development and publishing of company Operational/Quality metrics.
- Motivates and drives continuous improvement.
- Serves as the Deputy Management Representative for the Quality Management System (QMS).
- Responsible for regular Quality Management Reviews.
- Develops, implements, manages, and maintains quality systems globally for all NuVasive locations.
- Determines operational strategies and exercise judgment to define procedures and policies to accomplish departmental objectives; and lead execution of those strategies.
- Responsible to lead, organize and direct all internal and external quality system audits globally for all NuVasive locations.
- Assess quality related issues associated with business development activities, to support due diligence and partnering/licensing opportunities.
- Provide expertise to ensure QSR requirements and quality standards are recognized, understood and maintained across the Company.
- Budgetary and managerial responsibility for Quality Assurance.
- Provide counsel to all disciplines to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
- Lead, manage and ensure proper training to any relevant change management programs throughout the company.
- Represent QA at senior management, project and review meetings.
- Lead the development and implementation of new Quality process and procedures within the organization and eventually company-wide including design, risk management, manufacturing, validation, customer feedback etc. necessary for the continued compliance of the quality system.
- Main Quality liaison with our worldwide customers, regulatory agencies and suppliers within the corporation.
- Lead any customer issue investigations on a worldwide basis.
- Continue to develop the Quality Assurance department brand and work to identify areas of growth & development for QA team. Mentor and develop quality staff.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
Nature and Scope:
- Leads an entire function for a sub-region or significant business group; or leads a sub-function for a division or major region; or is a leader for a major global team. Directs and controls activities through other senior managers with overall responsibility for the direction of assigned areas.
- Creates and drives long-term strategy for an entire segment or major subset of function. Very little operational and tactical responsibility.
- Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking. Plays a key role in the development of critical projects, programs, and people within area of influence.
- Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.
- Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters. Influences policymaking
Directs and controls the activities of a broad functional area through several department managers within the company. Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.
Typically requires a minimum of 10- 15 years of related experience with a Bachelor’s degree; or 10 years and a Master’s degree; or a PhD with 5+ years experience; or equivalent experience.
- In-depth knowledge of ISO13485:2016 and MDSAP
- Excellent in depth knowledge of US FDA Quality System Requirements (QSR), ISO9001, MDD, and ISO 13485.
- Experience with orthopedic implant product design and project development.
- Experience in medical device or pharmaceutical industry.
- Must be detail oriented.
- Must possess superior teamwork and organizational skills.
- Excellent communication (both written and verbal), influential and negotiating skills, allowing the effective communication of complex information to a wide variety of audiences and leveraging for the best outcome.
- Analyze current processes, develop regulatory metrics and scorecards and institute data-based process improvements which will facilitate the product registration process and align with corporate and business unit goals.
- Ability to develop high performance teams that pursue and achieve excellence.
- Must be a collaborative facilitator and leader, building consensus while championing global regulatory initiatives.
- Successfully transfers knowledge both in one on one mentoring sessions and in group training situations.
- Possesses a passion for our internal and external customers; builds teams, processes and communications plans aligned with customer needs.
- Exhibits sound judgment and displays a willingness to make timely decisions including appropriate team members in the decision-making process.
- Understands how to communicate changes effectively, build commitment and overcome resistance, prepare and support those affected by change, monitor transitions and evaluate results.
- Generates creative solutions to issues as well as facilitates creative solutions from a group.
- Effectively leads high level initiatives.
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
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