My client is seeking a Quality Manager to oversee inspection at their site in Rochester, NY. You will be responsible for Receiving Inspection, In process Inspection, Floor Inspection, Clean Room Inspection and Final Inspection across all shifts. This will be an important role in the leadership group and report directly into the Director of Quality.
Client Details
My client is a multinational company specialising in advanced plastics and composite materials. They focus on the design, development, and production of medical-grade plastic components, devices, and products for the healthcare and pharmaceutical industries.
Description
The key responsbiliites of the Quality Inspection Manager will be:
Leadership & Management: - Lead and manage the quality inspection team, providing guidance and performance feedback.
- Establish and maintain quality inspection protocols, ensuring they comply with industry standards and regulatory requirements (ISO 13485, FDA, etc.).
- Collaborate with cross-functional teams (Production, R&D, Engineering) to ensure that quality expectations are met at every stage of the production process
Inspection & Quality Control:
- Oversee daily operations of quality inspections for incoming materials, in-process production, and finished products.
- Ensure that all medical devices and components meet the required specifications and standards.
- Implement and maintain the use of testing instruments and inspection equipment.
- Analyze inspection results, identifying trends and opportunities for process improvements.
Compliance & Documentation:
- Ensure compliance with quality management systems, including GMP (Good Manufacturing Practices) and regulatory requirements for the healthcare industry.
- Maintain up-to-date and accurate inspection records, including documentation for audits and regulatory reviews.
- Prepare quality inspection reports and communicate findings to senior management.
Continuous Improvement:
- Identify and implement continuous improvement initiatives within the quality inspection process.
- Lead root cause analyses and corrective action processes for any non-conformances detected.
- Work closely with suppliers and the procurement team to improve the quality of incoming materials.
Profile
The successful Quality Inspection Manager will have:
Education:
- Bachelor's degree in Engineering, Quality Management, or a related field. Advanced degree preferred.
Experience:
- Minimum of 5 years of experience in a quality assurance or quality control role, preferably in the medical device or pharmaceutical industry.
- Proven experience in a leadership or managerial role.
- In-depth knowledge of ISO 13485, GMP, FDA regulations, and other relevant industry standards.
Skills & Competencies:
- Strong analytical skills and attention to detail.
- Excellent problem-solving and decision-making abilities.
- Proficient in the use of quality inspection tools, techniques, and software.
- Exceptional communication and leadership skills.
- Ability to work in cleanroom environments and understand cleanroom protocols.
If interested, please apply using the link the below. Qualified applicants will be contacted within 24-48 hours of submittal.
Job Offer
My client can offer the following:
- Competitive Base Salary
- Bonus Potential
- Excellent Benefits including 401k company match
- Growth Opportunity
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