Vice President of Quality

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Scientia Vascular is a dynamic and rapidly growing company developing and commercializing differentiated technologies that facilitate vascular access. Scientia Vascular creates unique products and solutions to enable and advance better patient care for physicians treating neurovascular and peripheral diseases. We are seeking a dynamic leader to lead the Quality organization to provide leadership and direction related to product quality assurance and control, quality engineering, and compliance.

The role of the VP of Quality is to ensure that the Quality organization effectively oversees and implements the required compliance initiatives for the business. Additionally, you will lead the organization for compliance to all established procedures and compliance activities.

• Product Quality Assurance and Control – Responsible for quality professionals that focus on the quality of products in development and production. Responsibilities also include leadership in supplier management, production, product release, CAPA, and complaint investigation and resolution. Identifies and mitigates product quality risks.
• Quality Systems – Responsible for organizations that support business process and compliance, internal audits, records management, and document control, CAPA, complaint management, medical device and vigilance reporting and management of quality data and metrics.
• Compliance – Oversees the overall strategy and process of compliance with regulations. Ensures compliance with all regulatory requirements pertaining to product changes. Ensures the company is in compliance with regulations and is prepared for internal and external audits.
• Management Representative – Provides overall quality performance and guidance for implementation of improvements, and corrective and preventive actions related to processes that affect quality.

• This position has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, and proactively identify and document potential nonconformance issues.
• Assesses the current status of and develop the quality organization and develops and implements the strategic vision and tactical plans consistent with Scientia Vascular Quality Policy and objectives.
• Ensures the development and manufacture of products that consistently meet and exceed customer requirements.
• Works to achieve the overall objectives of the company and ensures that quality strategies are aligned.
• Provides leadership and vision with a focus on prevention, continuous improvement, and customer satisfaction.
• Ensures the business is in a constant state of readiness for FDA, ISO, and regulatory audits.
• Manages budgets assuring effective capacity and resources in support of company objectives.

• BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualifications.
• 15 years of progressive leadership responsibility with at least 10 years in the medical device industry.
• Progressive Quality leadership experience, including “hands-on” advanced quality systems development.
• Strong leadership ability, coupled with superior interpersonal, communication and influencing skills.
• Experience with Quality in a manufacturing environment.
• Knowledge and experience with advanced quality systems, concepts, regulatory compliance requirements and applied statistical concepts.
• Demonstrated knowledge of interpretation and application of QSR, MDD, ISO 13485 and other international standards.
• Ability to make sound decisions under pressure with reasonable foresight as to outcomes.
• Demonstrated expertise in interpretation and pragmatic application of Quality standards.
• Neurovascular industry experience and disposable/single use devices are preferred.
• Must be able to pass a standard background check and drug test.
• Must be authorized to work in the US without the need for sponsorship.
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Location

Onsite at 2460 S 3270 W, West Valley City, Utah 84119.

Job Type

Fu…