Quality Compliance 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 quality compliance for complaint handling, medical device and vigilance reporting, product risk assessments, internal / external audits, and Corrective and Preventative Action (CAPA).

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

• Process ownership for EU MDR quality system remediation
• Support for CAPA, complaint management, medical device and vigilance reporting, internal and external audits.
• Work closely with Operations, Quality, and Sales / Marketing personnel during complaint intake, processing, investigation, and closure.
• Support the issue escalation process as an input into the field action and recall process.
• Develop and monitor quality data and metrics.
• Performs all activities quality compliance with a focus on prevention, continuous improvement, and customer satisfaction.
• Support the company is in a constant state of readiness for FDA, ISO, and customer 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.
• Interface with regulatory agencies for facility and product registrations, audit preparation documentation, and Small Business Applications.
• Work closely with Finance and Sales & Marketing personnel with the financial relationship with healthcare providers
• Additional duties and responsibilities as assigned

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 1 years in the medical device industry
• Strong leadership ability, coupled with superior interpersonal, communication and influencing skills.
• Experience with Quality in a medical device manufacturing environment.
• Knowledge and experience with quality systems, concepts, regulatory compliance requirements and applied statistical concepts.
• Demonstrated knowledge of QSR, MDD, ISO 13485, ISO 14971 and other international standards.
• Post Market Surveillance activities in support of EU 2017 / 745 (MDR) and Global Post Market regulatory requirements a plus.
• 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

Commitment to Equal Opportunity :

The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds.

Visit our website and learn more about us at www.scientiavascular.com.