Quality Engineer
Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Were searching for a Quality Assurance Engineer who thrives in a regulated highprecision environment. If you have a keen eye for detail a passion for medical device compliance and the ability to drive quality improvements we want to hear from you.
Responsibilities include:
- Ensuring Compliance: Maintain and enhance the Quality Management System (QMS) to meet ISOFDA QSR ISO 13485 and ISO 17025 standards.
- Process Optimization: Create review and improve Standard Operating Procedures (SOPs) Work Instructions (WIs) and Form Control Documents (FCDs) to align with regulatory requirements.
- DataDriven Decision Making: Analyze SPC charts for process parameters conduct risk assessments (FMEA) and validate internal change management data before product commercialization.
- Auditing & Validation: Lead and participate in internal audits ensuring compliance with ISO standards and customer requirements.
- Customer Focus: Manage customer complaints oversee Return Material Authorization (RMA) processes and lead weekly complaint review meetings (TICS) for resolution tracking.
- Continuous Improvement: Drive Kaizen initiatives participate in root cause analysis and contribute to process excellence strategies.
- Training & Leadership: Develop and implement training programs evaluate competency and ensure compliance with updated quality protocols.
- Recall Management: Serve as the Recall Coordinator leading both mock and actual recall activities.
What You Bring to the Table:
- Education: Bachelors Degree in Applied Mathematics (with statistics) Engineering or a related field.
- Experience: 25 years in quality engineering within the medical device industry or 10 years in lieu of a degree.
- Technical Skills: Proficiency in Minitab Excel Access PowerPoint and Word.
- Regulatory Expertise: Handson experience with FDA QSR ISO 13485 and ISO 14971.
- Validation Knowledge: Familiarity with Test Method Validation (TMV) Corrective and Preventive Actions (CAPA) and nonconformance management.
- Leadership & Communication: Ability to collaborate crossfunctionally and drive quality initiatives.
What We Offer:
- A dynamic fastpaced environment where quality is paramount.
- The opportunity to make a direct impact on the safety and effectiveness of medical devices.
- A culture that values continuous improvement and professional development.
If youre ready to elevate your career in quality engineering and make a difference in the medical device industry apply today!
Equal Opportunity Employer Statement:
We are an equal opportunity employer and do not discriminate based on race color religion sex national origin age disability or any other protected category. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Employment Type
Full Time
