Summary:

As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads and assists in investigations, root cause analyses, corrective actions, and the management of nonconformance and CAPA processes. The ideal candidate possesses a robust background in quality systems, adept problem-solving abilities, and a steadfast commitment to upholding quality standards within the medical device industry.

Key Responsibilities:

Standardize process and reporting protocols to accurately document nonconformances, CAPAs, and associated corrective actions in compliance with regulatory directives within the medical device industry.
Supervise, gather, and analyze quality data, and furnish reports on external and internal audit observations and the status of corrective actions.
Collaborate with assigned business lines to conduct inquiries into product quality issues, deviations, out-of-specification occurrences, and nonconformances, ensuring swift and effective resolutions.
Develop training materials and resources to enable staff to employ root cause analysis methodologies (such as 6M, Fishbone, 5 Whys, etc.) to identify underlying factors contributing to nonconformances.
Create and execute CAPAs to address identified root causes and prevent the recurrence of nonconformances, ensuring clear definition, timely execution, and effective tracking to completion.
Compile and deliver reports summarizing investigation findings, root causes, corrective actions, and outcomes to management and relevant stakeholders.
Collaborate with cross-functional teams, including Quality, Regulatory, Operations, R&D, etc., to implement process enhancements based on analyses from nonconformance investigations.
Monitor the efficacy of implemented corrective actions, utilizing key performance indicators to assess progress and drive continual improvement.
Stay abreast of pertinent quality standards, regulatory requirements, and industry best practices related to nonconformance and CAPA processes.
Responsible for overseeing and reporting on quality data in other designated quality system processes, as assigned.

Qualifications: Education and Experience:

Bachelor's Degree in Life Sciences or a related technical discipline (e.g., biomedical engineering) or field.
Minimum of 5 years of experience in an ISO 13485 environment.
At least 3 years of direct experience in nonconformance and CAPA investigation within the medical device industry.
Previous experience supporting and facilitating internal and external audits within the medical device field.

Certificates, Licenses, Registrations:

Certification as a quality auditor or similar industry certification.

Benefits:

Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include:

Health Insurance:
High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually.
High Preferred Provider Organization (PPO)
Low Preferred Provider Organization (PPO)
Flexible Spending Account (FSA)
Dental Insurance
Vision Insurance
Basic Life Insurance (Employer-paid)
Supplemental Life Insurance
Short-term Disability Insurance (Employer-paid)
Long-term Disability Insurance
401(k) Plan with a 4% Employer Match
Paid Time Off (accrued at 120 hours per year)*
9 Paid Holidays
Access to Continuing Education and Seminar Programs
Employee Assistance Program (EAP)
Fitness Room Access