Quality Compliance Manager Jobs

Quality Compliance Manager

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.

What you will do:

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:

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

Required qualifications include:

• Ability to make sound decisions under pressure with reasonable foresight as to outcomes.
• Knowledge and experience with quality systems, concepts, regulatory compliance requirements and applied statistical concepts.
• Strong leadership ability, coupled with superior interpersonal, communication and influencing skills.
• Demonstrated knowledge of interpretation and application of QSR, MDD, ISO 13485, ISO 14971 and other international standards.
• BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualifications.
• Demonstrated expertise in interpretation and pragmatic application of Quality standards
• Post Market Surveillance activities in support of EU 2017/745 (MDR) and Global Post Market regulatory requirements a plus.
• Experience with Quality in a medical device manufacturing environment.
• At least 5 years in the medical device industry, with both progressive QA leadership experience and “hands-on” quality systems development for post market surveillance activities including complaint handling and investigation, medical device and vigilance reporting, and product risk assessments.

Key benefits we provide:

• 401k Plan (with an awesome employer match!)
• Life Insurance (company paid)
• Medical, Dental, Vision insurance
• Employee Assistance Program (company paid)
• Generous Paid Time Off (PTO)
• Paid Parental Leave
• Short-Term & Long-Term Disability Insurance (company paid)
• Paid Holidays
• Employee Wellness Program (company paid)

Starting annual salary range: $95,000 - $130,000 DOE

Location: 3487 W 2100 S, Suite 100, West Valley City, UT 84119

Job Type: Full-time, Exempt

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.