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Lead Quality Assurance Engineer
2 months ago
Location:
Hybrid
Company Overview:
At Olympus Corporation of the Americas, we are dedicated to enhancing lives through innovative medical technology. Our mission is to promote healthier, safer, and more fulfilling lives for individuals worldwide.
Role Overview:
We are seeking a skilled Quality Assurance Engineer to oversee the design, development, and management of quality assurance projects for our legacy product lines. This role is crucial in ensuring that our products meet the highest standards of quality and compliance.
Key Responsibilities:
- Spearhead the execution of the Production Release Process for components and finished products.
- Lead complex projects aimed at quality enhancement initiatives.
- Direct cross-functional teams towards compliant and efficient solutions for intricate challenges.
- Conduct Process and Design Risk Analyses.
- Provide guidance on quality regulations to various departments.
- Oversee multiple product Design Control activities for new product development.
- Support Process and Design Validation activities, including software validation.
- Implement cost of quality concepts, focusing on data collection and reporting.
- Collaborate with Manufacturing Engineering to create necessary documentation for manufacturing processes.
Qualifications:
Required:
- Bachelor's Degree in Engineering.
- At least 5 years of experience in Quality Engineering within a regulated medical device environment.
- Proficient in technical problem-solving using Six Sigma methodologies.
- Strong background in Sustaining Engineering and Post Market Surveillance.
- Knowledgeable in statistics, sampling strategies, and experimental design, with experience in statistical software tools.
- Familiarity with Risk Management practices and regulatory standards.
Preferred:
- Excellent written and verbal communication skills.
- Ability to excel in a fast-paced, dynamic environment.
- Highly organized, self-motivated, and adept at prioritizing tasks.
- Proficient in presentation development and public speaking.
Why Choose Olympus?
We prioritize the well-being of our employees, offering competitive salaries, comprehensive benefits, and a supportive work-life balance. Join us in our commitment to diversity and inclusion, where every employee is valued and empowered to thrive.
About Olympus:
Olympus is a global leader in medical technology, employing over 31,000 individuals worldwide. We are committed to fostering an inclusive workplace that respects diverse perspectives and encourages innovation.
