Quality Engineer supporting product development and quality assurance at Evergen. Leading investigations, supporting supplier qualifications, and ensuring compliance with standards.
About the role
- Manage Global QA Operations for Logistics & Distribution ensuring product quality in healthcare distribution channels. Lead a diverse team and drive compliance with regulatory standards while developing strategic quality programs.
Responsibilities
- Manage the Global QA Operations for Logistics & Distribution (L&D) to ensure product quality is maintained throughout the Teleflex distribution process
- Support the Global QA L&D Operations process in conjunction with Global Operations, Global Logistics & Distribution and Global Quality
- Provide support to North American Distribution Center and Global Distribution Centers to ensure adherence to required regulatory and corporate compliance systems
- Manage strategic programs as part of the Global QA Logistics & Distribution organization
- Responsible for detecting, identifying, correcting and preventing recurrence of problems within the relevant quality system elements
- Develop road maps/methodologies to move from current state to future state including changes and implications to existing architecture and systems
- Provide Leadership to the Global L&D QA team including key talent development, mentoring, coaching, effective organisational structure development and motivation of personnel
- Implement Supplier Controls & Management in the 3PL network and develop strategy for support of Supplier Quality in Regional offices
- Provide guidance and recommendations in relation to Quality requirements and the implementation and adherence to those requirements
- Leads a diverse team from multiple cultures by sustaining an inclusive and empowered organization which is dynamic to business needs and adapts appropriately
Requirements
- B.S Degree in Science, Medical Technology or related discipline
- 10+ years experience in Quality Assurance and/or Regulatory Affairs of medical products
- Extensive knowledge of FDA/ISO/CE QMS & Regulatory Requirements with proven audit experience
- Broad Range of Quality experience including Supplier Management, Post Market and Distribution
- Proven People Management of multi-site teams
- Excellent IT skills & knowledge – MS applications, systems knowledge, WMS knowledge, SAP
- Strong project management skills and experience in leading virtual teams
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Quality Engineer ensuring compliance and quality assurance for medical device design and development at Johnson & Johnson in Minnesota. Collaborating with R&D and manufacturing for effective product launches.
Quality Engineer at EDAP TMS supporting the quality management system and continuous improvement initiatives. Collaborating on projects and conducting audits to ensure quality standards are met.
Quality Assurance & Compliance Officer maintaining high standards of documentation and compliance within behavioral health organization. Focused on audit processes and regulatory adherence in Hopewell, Virginia.
Quality Assurance Manager responsible for leadership in Quality Management Systems at a biotech company. Ensuring compliance, scalability, and driving culture of quality improvement.
Compliance Quality Assurance Manager ensuring compliance risk management at TD Bank. Leading independent reviews and providing strategic guidance for compliance structures and processes.
QA Engineer specializing in test automation handling functional and non - functional tests. Seeking a detail - oriented individual with experience in SQL and automated testing tools for a hybrid role in Santo Domingo.
Automation QA Engineer at Pwrteams maintaining tests and creating automation frameworks for diverse IT projects. Join our diverse team providing IT solutions for global customers.
Quality Assurance Technician responsible for testing and compliance in medical device manufacturing. Ensuring product standards and collaborating across departments at Terumo Medical Corporation.
Penetration Tester in AI cybersecurity firm Darktrace, focusing on identifying and mitigating security risks. Conducting penetration tests and collaborating with teams to enhance digital resilience.