What are the responsibilities and job description for the Snr Quality Engineer position at Clinician's Choice?
Company Description
For over fifty years, Clinician’s Choice has been a trusted provider of innovative products that address clinical challenges and deliver consistent results for dental professionals. Dedicated to supporting clinical excellence, we develop solutions that lead to superior outcomes for patients. Our products are available across North America and in over 50 countries worldwide. Clinician’s Choice is a division of Den-Mat Holdings, LLC. To learn more, visit www.clinicianschoice.com.
Role Description
This is a full-time, on-site Senior Quality Engineer position located in Lompoc, CA. The Senior Quality Engineer will oversee and ensure adherence to quality standards, implement quality management policies, and collaborate with cross-functional teams to maintain compliance with regulatory requirements. Responsibilities include conducting quality control inspections, analyzing data to identify trends or issues, managing processes to ensure efficiency, and providing technical guidance and leading continuous improvement initiatives. The role involves participation in audits and ensuring products meet both internal and external quality standards.
Qualifications
- Strong knowledge of quality control principles, quality assurance processes, and regulatory compliance requirements.
- Proven leadership and mentoring skills for company stakeholders.
- Ability to lead quality initiatives and drive results.
- Proficiency in analyzing data, identifying trends, implementing continuous improvement strategies, and developing and executing process validations for medical devices and pharmaceuticals.
- Experience in design controls as part of the product development and new product introduction processes (NPI).
- Experience in project management and cross-functional collaboration within a manufacturing or production environment.
- Ability to conduct audits, identify risks, and develop mitigation strategies to ensure compliance with quality standards.
- Bachelor's degree in Engineering, Quality Management, or a related field.
- Strong verbal and written communication skills, attention to detail, and problem-solving abilities.
- Familiarity with ISO13485 standards, FDA regulations (CFR 820, 803, 210/211), and other industry certifications is highly desirable.