Senior Quality Engineer - Medical Device Manufacturing

Are you a Quality Engineer who has 2+ years of experience in a Manufacturing setting? Do you have experience with ISO 9001? Do you have experience with testing equipment such as zygos or caliper tools? Do you have a degree in Engineering or a related field? If so, please read on and apply to the Senior Quality Engineer - Medical Device Manufacturing opening in Fishkill, NY.

Client Details

We are currently partnered up with a Medium Sized Medical Device Manufacturing Company in their search to add a Senior Quality Engineer - External Auditing to the team. This role will focus on maintaining compliance with ISO 9001 standards, overseeing testing equipment, and driving continuous improvement across the manufacturing process. The ideal candidate will have a strong background in quality management systems, testing methodologies, and a passion for ensuring product excellence.If you are interested please read on and apply to the Senior Quality Engineer - Medical Device Manufacturing job based in Fishkill, NY.

Description

The Senior Quality Engineer - Medical Device Manufacturing will be responsible for the following:

• Develop, implement, and maintain the Quality Management System (QMS) to meet ISO 9001 standards.
• Prepare for and lead internal and external audits.
• Ensure compliance with regulatory and customer requirements.
• Oversee the calibration, maintenance, and validation of testing equipment.
• Establish protocols for the use of optical testing tools and devices.
• Troubleshoot equipment-related issues and implement corrective actions.
• Define and monitor quality metrics across the production process.
• Conduct root cause analyses and implement corrective and preventive actions (CAPA).
• Collaborate with engineering and production teams to resolve quality issues.
• Lead quality improvement projects using Six Sigma, Lean, or similar methodologies.
• Propose and implement innovative solutions to enhance product reliability and manufacturing efficiency.
• Maintain accurate records of quality activities, including inspection data, non-conformance reports, and audit results.
• Provide detailed quality reports to management, including trend analysis and recommendations for improvement.

Profile

The Senior Quality Engineer - Medical Device Manufacturing will have the following qualifications:

• Bachelor's degree in Engineering, Quality Management, or a related field.
• Advanced degrees or certifications (e.g., Six Sigma, ASQ CQE) are a plus.
• Minimum 4-7 years of experience in quality engineering, preferably in optical or precision manufacturing.
• Demonstrated expertise in ISO 9001 implementation and maintenance.
• Proficiency in managing and calibrating testing equipment.
• Strong knowledge of quality management principles and methodologies.
• Excellent problem-solving and analytical skills.
• Proficient in quality tools such as FMEA, SPC, and statistical analysis software.
• Exceptional communication and leadership abilities.

Job Offer

The Senior Quality Engineer - Medical Device Manufacturing will be rewarded with the following:

• Base Salary of $80,000-$115,000 depending on experience
• Bonus
• 401K Match
• PTO
• Medical, Dental, Vision

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.