Quality Control Inspector
About the role
BPI Medical is seeking a quality control inspector to join our dynamic team. This role will play a critical part in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.
Responsibilities
- Conduct visual inspections, measurements, and functional tests on medical devices to verify compliance with regulations like ISO 13485 and FDA guidelines.
- Document inspection results and maintain accurate records in accordance with regulatory requirements.
- Use mechanical inspection equipment such as micrometers, calipers, and optical comparators to ensure product quality.
- Identify and report non-conformities or deviations to relevant personnel for investigation and corrective action.
- Participate in investigations of quality issues and collaborate with cross-functional teams to determine root causes and implement corrective and preventive actions.
- Ensure that inspection equipment and tools are calibrated and maintained according to regulatory requirements and company procedures.
- Develop and implement quality control procedures and work instructions to maintain consistent product quality.
- Collaborate with production staff and other stakeholders to address quality issues and drive continuous improvement.
- Participate in internal and external quality audits to ensure compliance with applicable regulations and standards.
- Communicate effectively with customers, suppliers, and other stakeholders on quality-related matters, including product quality, regulatory compliance, and quality system requirements.
Requirements
- A degree in a related field or equivalent experience.
- Proven experience in quality control and inspection of medical devices.
- Proficiency in using mechanical inspection equipment.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and follow established processes and procedures.
Qualifications
- Experience with ISO 13485 and FDA guidelines.
- Knowledge of medical device manufacturing processes.
- Understanding of quality management systems.
- Ability to work in a fast-paced, deadline-driven environment.
Skills
- Quality Control Inspection
- Medical Device Compliance
- Inspection Equipment Proficiency
- Problem Solving
- Communication
- Teamwork
Benefits
We offer a competitive salary, comprehensive benefits package, professional development opportunities, and a supportive work environment that encourages innovation and growth.
Pay
Competitive salary based on experience and qualifications.
Schedule
Full-time position with flexible hours to accommodate the needs of the role and the team.
Contact
To apply, please submit your resume and cover letter detailing your experience and interest in this role. We look forward to hearing from you!
We are proud to be an Equal Opportunity Employer and are committed to fostering a diverse and inclusive workplace. If you have any questions about our commitment to diversity and inclusion, please contact us.