Quality Engineer

Job Description

Job Description

About Scientia Vascular :

Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.

Job Position Summary :

This position will work in all aspects of the Scientia Vascular Quality System related to design quality assurance, product quality assurance, product quality control, and regulatory compliance.

They will work closely with all other departments to develop, implement, and monitor quality systems to deliver quality product to customers while maintaining regulatory compliance.

This position will work under general direction and have latitude in determining how to solve problems.

Primary Responsibilities :

• Work with all other departments to assure product design conforms to internal specifications, customer, and regulatory requirements.
• Performs all activities with a focus on prevention, continuous improvement and customer satisfaction.
• Ensures the company is in a constant state of readiness for FDA, ISO, and customer audits.
• Work closely with Operations and Quality personnel to monitor Manufacturing processes.
• Review designs, changes, and plans of specifications and processes.
• Develop and monitor quality data and metrics.
• Assists in CAPA, complaint management, medical device and vigilance reporting.
• Assists in all aspects of supplier management.
• Assists in internal and external audits.
• 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.

Requirements :

• BA / BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and / or professional qualifications.
• At least 5 years in the medical device industry.
• Progressive QA leadership experience, including hands-on 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 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 we provide :

• 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 Calm.com
• Employee Assistance Program
• An environment of belonging where everyone can thrive
2 days ago