Synova Partners
Synova Partners is engaged on a VP of Quality
search for a market-leading neurovascular player who are scaling rapidly. Candidates must be based in or willing to relocate to
Salt Lake City, Utah. The VP of Quality will be responsible for spearheading the Quality Department and providing leadership and direction related to all things quality assurance, quality control, quality engineering, and compliance. Primary Responsibilities Product Quality
— Responsible for Quality Engineering professionals that focus on quality aspects of development, production, and support. Responsibilities include leadership in supplier management, production, qualification, product release, CAPA, and complaint investigation and resolution.
Quality Systems
— Responsible for organizations that support business processes and compliance, internal audits, records management, 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. Ensure that the site is in compliance with regulations and is prepared for internal and external audits.
Management Representative
— Provides overall Quality performance and guidance for the implementation of improvements, and corrective and preventive actions related to processes that affect Quality.
Requirements 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.
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search for a market-leading neurovascular player who are scaling rapidly. Candidates must be based in or willing to relocate to
Salt Lake City, Utah. The VP of Quality will be responsible for spearheading the Quality Department and providing leadership and direction related to all things quality assurance, quality control, quality engineering, and compliance. Primary Responsibilities Product Quality
— Responsible for Quality Engineering professionals that focus on quality aspects of development, production, and support. Responsibilities include leadership in supplier management, production, qualification, product release, CAPA, and complaint investigation and resolution.
Quality Systems
— Responsible for organizations that support business processes and compliance, internal audits, records management, 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. Ensure that the site is in compliance with regulations and is prepared for internal and external audits.
Management Representative
— Provides overall Quality performance and guidance for the implementation of improvements, and corrective and preventive actions related to processes that affect Quality.
Requirements 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.
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