Quality Engineer

The Quality Engineer will be working directly with the Quality, Manufacturing and Production team on the floor. Responsibilities include developing and implementing quality assurance processes, conducting audits, and collaborating with cross-functional teams to address quality issues.

Client Details

My client is a distinguished provider of precision medical components. They work in grinding craftsmanship, blending traditional skills with modern technology. The company specializes in manufacturing components for orthopedics, minimally invasive surgery, and interventional therapies, including ortho-pins, mandrels, cannulated drills, and Nitinol orthopedic staples. My client is ISO 13485 certified and operates FDA-registered facilities, ensuring adherence to the highest quality standards. Employees have praised the company's investment in advanced equipment and the supportive work environment fostered by approachable management. With a commitment to innovation and excellence, my client has become a preferred supplier for medical OEMs worldwide.

Description

Quality Engineer:

• Hands on Quality Control experience

• Quality Management System Development: Develop and support company quality policies, initiatives, and procedures to ensure compliance with ISO 13485 standards.

• Issue Investigation and Resolution: Lead or support teams in investigating manufacturing quality issues to resolve complaints, non-conforming products, and corrective and preventive actions (CAPA).

• Process Validation: Develop validation and qualification protocols, supporting the execution of manufacturing process and product qualifications and validations.

• Risk Analysis: Apply risk analysis techniques, including Process Failure Modes and Effects Analysis (PFMEA), to identify and mitigate potential issues.

• Change Control Management: Manage change control processes and notifications with suppliers and customers to ensure quality standards are maintained.

• Inspection Requirements Definition: Define in-process and incoming inspection requirements to maintain product quality throughout production.

• Quality Data Analysis: Analyze production data, customer complaints, non-conforming products, scrap, and quality costs to identify trends and areas for improvement.

• Project Management: Manage multiple projects simultaneously, ensuring accountability and achievement of scheduled milestones and deliverables.

• Blueprint Interpretation: Interpret engineering blueprints, including Geometric Dimensioning and Tolerancing (GD&T), to ensure product specifications are met.

• Measurement Verification: Verify dimensions of finished workpieces for conformance to specifications using tools such as optical comparators, micrometers, pin gauges, and vision inspection systems.

Profile

Quality Engineer:

• 5+ years of experience in Quality / Manufacturing

• Quality Management Proficiency: Experience developing and implementing quality policies and procedures compliant with ISO 13485 standards.

• Problem-Solving Skills: Ability to lead or support teams in investigating and resolving manufacturing quality issues, including handling complaints, non-conforming products, and CAPA.

• Process Validation Expertise: Skilled in developing validation and qualification protocols, and supporting the execution of manufacturing process and product qualifications.

• Risk Analysis Knowledge: Familiarity with risk analysis techniques, such as Process Failure Modes and Effects Analysis (PFMEA).

• Change Control Management: Experience managing change control processes and notifications with suppliers and customers.

• Technical Skills: Proficiency in blueprint reading, including Geometric Dimensioning and Tolerancing (GD&T), and the use of measurement tools like optical comparators, micrometers, pin gauges, and vision inspection systems.

• Communication and Teamwork: Excellent written and verbal communication skills, a positive attitude, and the ability to work effectively as a team player.

Job Offer

• Competitive Salary: A competitive and industry-aligned salary to attract and retain top talent.

• Healthcare Benefits: Comprehensive health insurance coverage, including medical, dental, and vision plans.

• Retirement Plans: Participation in retirement savings plans, such as 401(k), with potential employer contributions.

• Paid Time Off: Generous vacation, holiday, and sick leave allowances to support work-life balance.

• Professional Development: Opportunities for ongoing professional development and training to enhance skills and career advancement.

• Workplace Wellness: Wellness programs and initiatives to promote a healthy work environment.

• Life Insurance: Coverage for life insurance to provide financial protection for employees and their families.

• Employee Recognition: Recognition programs to acknowledge and reward employee contributions and achievements.

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.