Senior Quality Systems Specialist

Asensus Surgical • Durham, NC

87d

About The Position

Asensus is hiring a Senior Quality Systems Specialist. This role will be part of the Global Quality team and will be responsible for activities associated with product and processes support at Asensus globally and associated with global quality assurance and document control. The Senior Quality Systems Specialist ensures that all activities for Quality Systems are followed and documented to provide a safe and effective product that meets customer needs, while maintaining compliance.

Requirements

• Bachelor's degree in Engineering or related field.
• 4/5+ years in a quality role in the Medical Device field or related industry.
• Knowledge of the standards related to medical device manufacturing, including ISO 13485, 21 CFR Part 820 and ISO 14971 preferred.
• Previous experience with CAPAs is a must.
• ISO 13485 and FDA inspections experience.
• CE inspections experience is a plus.
• Basic knowledge of Medical device directive and MDR 2017/745 is considered a plus.
• Understanding of regulatory and quality requirements.
• Solid understanding of approaches to work breakdown, prioritization, resource allocation, and problem solving.
• Working knowledge of common quality tools.
• Experience working in cross-functional teams.
• Self-starter with the ability to work towards goals with little day-to-day supervision.

Nice To Haves

• Master's degree in Engineering or related field.
• CE inspections experience.
• Basic knowledge of Medical device directive and MDR 2017/745.

Responsibilities

• Ensures compliance with global company quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
• Supports Global Quality System ensuring that all activities for ISO 13485 and 21 CFR compliance are followed and documented.
• Leads CAPAs globally, coordinating the board and ensuring CAPAs resolution.
• Conducts/leads audits as appropriate (internal and external).
• Supports Third Party Audits and acts as reference person for the US site.
• Supervises document control and change support.
• Supports company training to ensure compliance with ISO 13485.
• Supports supplier management (audits, qualification, monitoring, CAPAs and associated activities).
• Supports Product Evaluation Board generating metrics and presenting quarterly evaluations of external feedback and trends.
• Supports quality metrics, dashboards and KPIs.
• Assists with risk management activities including support regarding creation and maintenance of risk management files by product and process.
• Supports complaints as needed.
• All other essential duties as directed.

Benefits

• A culture-driven environment to achieve our mission and deliver remarkable results.
• Coworkers committed to collaboration and winning the right way.
• Quality products that improve the lives of our customers and patients.
• Ability to discover your strengths, follow your passion and find your own rewarding career.
• Flexible, engaging work environment.
• Competitive benefits package.

What This Job Offers

• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree