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.

Quality Engineer Role:

This position will work in all aspects of the Scientia Vascular Quality System with a primary focus on product quality assurance. 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 has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, and proactively identify and document potential nonconformance issues.

Depending on experience, this position will work under general direction and have latitude in determining how to solve problems while maintaining focus on prevention, continuous improvement, and customer satisfaction.

Primary Responsibilities:

• Work closely with cross-functional partners to ensure product design conforms to internal specifications, customer, and regulatory requirements in order to ensure quality product
• Provide Quality guidance to Manufacturing Engineers, Technicians and Product Builders
• Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors. Depending on experience, opportunities may exist to mentor or manage a limited number of technicians, interns, or other more junior engineers
• Work closely with Operations and Quality personnel to monitor Manufacturing processes
• Partner with Manufacturing Engineering to review and investigate defects, perform root cause analysis, and develop and implement line improvements
• Review designs, changes, and plans of specifications and processes
• Develop and monitor quality data and metrics related to production
• Assist in CAPA, complaint management, and medical device and vigilance reporting
• Assist in all aspects of supplier management
• Assist in internal and external audits
• Lead and/or support projects to update and revise Quality Systems and Procedures as necessary to meet the current needs of the organization while maintaining compliance to all applicable standards
• Design and qualify inspection test methods and equipment.
• Act as direct support for Transfer Engineers during process development and process transfer into production
• Update and assist in the generation of the PFMEA risk documentation
• Own and support Nonconformance Report investigations and any related actions for NCRs generated in incoming or production spaces
• Take action to maintain and improve product quality
• Compile and present data for Management Review
• Ensures the company is in a constant state of readiness for FDA, ISO, and customer audits
• Other duties as assigned with or without accommodation

Requirements:

• BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualifications
• Experience in a highly regulated industry
• Knowledge and experience with quality systems, quality and manufacturing concepts, regulatory compliance requirements and applied statistical concepts
• Experience with medical device R&D, Regulatory Affairs, Manufacturing or Quality. Preferably in or around a manufacturing environment
• Ability to make sound decisions under pressure with reasonable foresight as to outcomes
• Good oral and written communication skills
• Demonstrated knowledge of interpretation and application of QSR, MDD, EU MDR, ISO 13485 and other international standards
• Demonstrated expertise in interpretation and pragmatic application of Quality standards
• Strong leadership ability, coupled with superior interpersonal, communication and influencing skills
• Progressive leadership experience, including “hands-on” quality systems development

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.

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