Quality Director
Quality Director
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1 Vacancy
Job Description
About ScientiaVascular:
Our mission is to save lives. Scientia Vascular is aleading innovator and manufacturer of endovascular medical devices. We usemicromachining and microfabrication processes to manufacture products thatprovide physicians with enhanced performance for optimal outcomes for theirpatients.
Quality Director Job Description:
Lead the QA/QC function providing leadership and direction related to quality assurance quality control regulatory compliance regulatory affairs and compliance. The role of the Director is to develop and implement quality systems across the organization in order to deliver quality product to customers and to provide strategic guidance necessary to maintain regulatory compliance. The director provides the strategic leadership and tactics for QA to proactively integrate the essential elements of the Quality System requirements in support of the business goals and regulatory requirements.
Primary Responsibilities:
- Product Quality Responsible for QA 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 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. Ensure that the site is in compliance with regulations and are 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 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
Requirements:
- BA/BS degree in a Life Science Engineering Physical Science a related field of study or equivalent work experience and/or professional qualifications
- 10 years of progressive leadership responsibility with at least 5 years in the medical device industry
- Progressive QA 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
Key benefits weprovide:
- Medical Dental Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- Short-Term & Long-Term Disability Insurance (company paid)
- Subscription to
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment toEqual Opportunity:
The Scientia Vascular culture iscentered on the principals of equal opportunity for all employees. Consistentwith our culture all qualified applicants will receive consideration foremployment without regard to race color religion gender gender identity orexpression family status marital status sexual orientation national origingenetics disability age or veteran status or any other non-merit based orlegally protected grounds.
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Required Experience:
Director
Employment Type
Full Time
