VP, Ops & Quality Assurance

VP, Ops & Quality Assurance Benefits Medical, Dental, and Vision Insurance, 401(k), and stock options. NOTE: You must have 10+ years of experience in the MedTech (or related) industry in Quality and Operations leadership or management roles to be considered for this position. Spine or orthopedic industry experience preferred. Providence Medical Technology, Inc. is a privately‑held medical device company focused on innovation solutions for cervical spine conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. Our purpose is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.

LOCATION

This is a hybrid role located in Pleasanton, CA.

SUMMARY

The Vice President of Global Operations and Quality is a key part of the Management Team. They work cross‑functionally with all departments and key partners. They advise, develop, establish and implement strategic and tactical plans that deliver excellent results for our customers and the business. It is their responsibility to align the resources, processes, and lead the people of the Quality and Operations departments to support a sound commercial business activities and objectives. They use their extensive experience, influence, creativity, sound judgment, and subject matter expertise to drive departmental excellence to meet organizational goals. In all actions, the VP of Global Operations and Quality must emphasize and demonstrate a primary commitment to patient safety, product quality, and operational excellence.

MAIN RESPONSIBILITIES

Operations Departmental Management With Senior Leadership, plan, build and execute annual operating plan. Establish and implement departmental goals, procedures and policies. Set and maintain strategy with regards to inventory controls including forecasting and planning to ensure supply chain of production goods and demo materials. Develop and maintain dashboards and KPIs to keep leadership informed of financial and operational performance. Provide leadership and develop a strategy/related business cases for operational initiatives, to educate and support operational decisions to Senior Leadership. Operations Departmental Development Oversee systems administration, fulfilment, daily operations of personnel, purchasing and manufacturing. Improve the operational systems, process policies in support of organizational mission. Provide management reporting, of KPIs, business processes, and organization. Play a significant role in long‑term planning, including initiatives geared toward operational excellence. Direct and coordinate operations in support of company’s growth including creating policies and strategic plans Commercial and Interdepartmental Client Service. Actively manage customer satisfaction through analysis of customer feedback, scrutiny of performance metrics and improvement of customer service systems and processes. Ensures inquiries from customers, distribution partners, direct reps, regulatory and other department heads are responded to adequately. Develop and maintain effective organization of responsibility, including efficient recruiting, training, coaching, recognition, workflow patterns, performance standards, delineation of duties and responsibilities, staffing levels and supervision. Maintain accurate, detailed and timely performance documentation for all team associates. Work with human resource activities such as determining staffing requirements, interviewing, hiring and training new employees. Quality Departmental Management With Senior Leadership, Plan, build and execute annual operating plan. Develop and implement departmental goals, procedures and policies to ensure regulatory compliance to FDA 21 CFR Part820, 21 CFRPart 1271, ISO 13485, California H&SC §111615, MDD and MDR, and others as required. Serve as Company’s Management Representative. Oversee, manage, and continuously improve the Quality Management System; including document control systems, deviations, CAPAs, investigations, complaints, etc. Assist oversight of the independent quality units at contract manufacturers, test labs, and distributors. Provide leadership and develop strategy and related business cases for operational initiatives, to educate and support operational decisions to Sr. Leadership. Manage all QMS related training records of company employees. Implement and ensure compliance for design control and risk management activities. Manage and guide inter‑departmental CAPA and NC investigations, ensuring accurate, timely closures. Host or participate in MRB to ensure timely disposition and problem resolutions. Guide or perform product releases, including IQC on resolving daily incoming, WIP and final inspection issues. Participate in risk management activities. Manufacturing and Operational Management With Senior Leadership, plan, build and execute annual operating plan. Work with R&D and Contract Manufacturers to set up commercial production capabilities for new and updated products in alignment with organizational goals. Work with manufacturing to ensure consistent, timely production of high‑quality products are manufactured, available, and distributed as the business requires. Work with R&D to compile, review, and approve DHRs and ECOs. Oversee use of engineering, scientific, and regulatory principles to guide quality decisions such as statistical analysis or DOE to identify sources of variations affecting products and processes including providing direction for process improvement activities. Develop, establish, and improve quality inspection criteria and requirements including but not limited to SOPs and WIs as needed. Develop, establish, and improve methods of process control.

QUALIFICATIONS

Bachelors Degree in Industrial Engineering, Manufacturing, or related field. 10+ Years of experience with increasing responsibility in medical device manufacturing or related field. 10+ Years of experience with increasing responsibility in similarly regulated industries. Experience in spine and/or orthopedics is preferred.

REQUIRED SKILLS AND ABILITIES

Effective as both a leader and individual contributor to produce deliverables and scope of responsibilities. Experienced Financial Management, Departmental Management and Team Development. Structure effective training programs and evaluate based on key metrics. Strong knowledge of manufacturing process and supply chain logistics. Strong knowledge of financial planning and analysis. Strong knowledge of information technologies including hardware, ERP, system integrations. Commercial and internal customer service experience. Our Mission is to establish Circumferential Cervical Fusion (CCF) as the standard of care for high-risk patients. #J-18808-Ljbffr Providence Medical Technology, Inc.