Quality Engineer Jobs

Job Title: Quality Engineer

About Scientia Vascular:

At 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:

As a Quality Engineer, you 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. You 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.
• Work closely with Operations and Quality personnel to monitor Manufacturing processes.
• Assists in CAPA, complaint management, medical device and vigilance reporting.
• Ensures 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.
• Review designs, changes, and plans of specifications and processes.
• Performs all activities with a focus on prevention, continuous improvement and customer satisfaction.
• Develop and monitor quality data and metrics.
• Assists in all aspects of supplier management.
• Assists in internal and external audits.

Requirements:

• Ability to make sound decisions under pressure with reasonable foresight as to outcomes.
• BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualifications.
• Strong leadership ability, coupled with superior interpersonal, communication and influencing skills.
• Hands-on quality systems development experience is a plus.
• Knowledge and experience with quality systems, concepts, regulatory compliance requirements and applied statistical concepts.
• Demonstrated expertise in interpretation and pragmatic application of Quality standards.
• At least 1 year of experience in the medical device industry.
• Demonstrated knowledge of interpretation and application of QSR, MDD, ISO 13485 and other international standards.
• At least 2 years of Quality Engineering experience in a manufacturing environment.

Key Benefits We Provide:

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

Starting Annual Salary: $75,000 - $85,000

Work Schedule: 1st Shift, 7:00am - 4:00pm, Monday - Friday

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

Job Type: Full-time

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.

Learn more about us at www.scientiavascular.com