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Scientia Vascular · 23 hours ago

Vice President of Quality

West Valley City, UT

Full-time

Onsite

Director/Executive

15+ years exp

Scientia Vascular is a dynamic and rapidly growing company developing and commercializing differentiated technologies that facilitate vascular access. The Vice President of Quality will lead the Quality organization to ensure effective oversight and implementation of compliance initiatives, focusing on product quality assurance, quality systems, and regulatory compliance.

Health CareManufacturingMedicalMedical Device

No H1B

Responsibilities

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

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

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

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

Qualification

Quality leadershipQuality systems developmentRegulatory complianceMedical device industryStatistical conceptsInfluencing skillsContinuous improvementInterpersonal skillsCommunication skillsDecision making

Required

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

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