The Quality Engineer develops and implements quality policies to ensure ISO 13485 compliance, leads investigations into manufacturing issues, non-conformances, and customer complaints through CAPA initiatives. They also create validation protocols, oversee process and product qualifications, and analyze data, feedback, and quality costs to drive continuous improvement
Client Details
My client is a trusted leader in precision manufacturing for the medical device industry, known for its commitment to quality, innovation, and excellence. The company specializes in producing high-precision medical components, ensuring strict adherence to ISO 13485 and other industry standards. With cutting-edge technology, advanced manufacturing processes, and a highly skilled team, my client delivers reliable, high-quality products that support life-saving medical advancements. Employees benefit from a collaborative work environment, long-term career growth, and a strong company culture that values teamwork, precision, and continuous improvement.
Description
- Develop & Implement Quality Policies - Ensure compliance with ISO 13485 and maintain a robust Quality Management System (QMS).
- Lead CAPA Investigations - Identify root causes of non-conforming products, customer complaints, and process deviations while implementing Corrective and Preventive Actions (CAPA).
- Support Manufacturing Process Validations - Develop and execute validation and qualification protocols for processes, equipment, and products.
- Conduct Internal & Supplier Audits - Ensure compliance with regulatory standards by overseeing internal audits and working with suppliers to uphold quality expectations.
- Analyze Production & Quality Data - Monitor trends in scrap rates, quality costs, and customer complaints to drive process improvements.
- Ensure Compliance with Industry Standards - Maintain adherence to FDA regulations, ISO 13485, and customer-specific requirements.
- Perform Risk Management Activities - Support risk assessments, FMEA analysis, and mitigation strategies to enhance product reliability.
- Oversee Calibration & Inspection Processes - Ensure quality control measuring devices are properly calibrated and inspections are performed accurately.
- Collaborate with Cross-Functional Teams - Work closely with engineering, production, and regulatory teams to optimize quality and manufacturing processes.
- Drive Continuous Improvement Initiatives - Implement lean manufacturing and Six Sigma principles to enhance efficiency and product quality.
Profile
- Expertise in ISO 13485 & FDA Regulations - Ensures full compliance with medical industry quality and regulatory standards.
- Strong Problem-Solving & Analytical Skills - Investigates root causes of quality issues and drives effective solutions.
- Experience with Process Validations & Risk Management - Develops validation protocols and conducts FMEA and risk assessments.
- Data-Driven Decision Making - Analyzes scrap rates, quality costs, and customer complaints to improve processes.
- Proficiency in CAPA & Internal Audits - Leads Corrective and Preventive Actions (CAPA) and ensures successful audit outcomes.
- Attention to Detail & Precision - Maintains the highest standards for medical component manufacturing and quality assurance.
- Strong Communication & Teamwork - Works closely with engineering, production, and regulatory teams to optimize quality processes.
- Hands-On Approach to Quality Control - Oversees calibration programs, inspections, and supplier quality management.
- Commitment to Continuous Improvement - Applies Lean, Six Sigma, and other quality methodologies to enhance efficiency.
- Passion for Medical Manufacturing - Dedicated to ensuring the production of high-precision
Job Offer
- 401(k) Match - A generous company-matched 401(k) plan to help employees build a secure financial future.
- Long-Term Career Growth - Many employees enjoy long tenures, reflecting job stability and a commitment to internal growth.
- Great Company Culture - A collaborative and supportive work environment that values teamwork, innovation, and continuous improvement.
- Comprehensive Benefits Package - Includes health, dental, and vision insurance to support employee well-being.
- Paid Time Off & Holidays - Generous PTO and paid holidays to promote work-life balance.
- Cutting-Edge Manufacturing - Work on high-precision medical components using advanced technology and quality systems.
- Job Stability in a Growing Industry - A well-established company with a strong reputation in medical device manufacturing.
- Supportive Leadership & Mentorship - A leadership team that prioritizes employee growth and success.
- Safe & Modern Work Environment - A clean, well-maintained facility with a focus on safety, efficiency, and precision.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.