Senior Quality Engineer

About the role

The Sr. Quality Engineer is responsible for ensuring the quality and compliance of our products and processes in accordance with ISO and FDA regulations within the medical device manufacturing process for our Class II and Class III medical devices.

Responsibilities

• Lead and conduct quality investigations, root cause analyses, and corrective and preventive actions (CAPAs) to address quality issues and ensure timely resolution.
• Develop and implement quality systems and procedures to ensure compliance with ISO and FDA regulations.
• Participate in cross-functional teams to ensure quality is built into all stages of the product development and manufacturing process.
• Lead and participate in design control and change control activities for development and manufacturing projects including review and update of design history files.
• Work with operations on lean initiative projects to improve quality and manufacturing efficiencies.
• Participate in cross-functional teams to develop manufacturing work instructions for new and existing products.
• Develop and implement operator training and qualification assessments.
• Conduct internal audits to assess compliance with quality systems and procedures.
• Interface with FDA and ISO auditors during inspections and provide necessary documentation and support.
• Evaluate suppliers to ensure their products and services meet quality standards.
• Develop and maintain quality metrics to track and monitor quality performance.
• Provide guidance and mentoring to other members of the quality team.
• Identify areas for continuous improvement and drive initiatives to enhance quality processes and systems.
• Stay up to date with changes in ISO and FDA regulations and industry best practices related to quality.

Requirements

• Bachelor’s degree in engineering, science, or a related field
• Minimum of 5 years of experience in a quality engineering role in a medical device or pharmaceutical company.
• Strong knowledge of quality control principles, methodologies, and tools used in the medical device industry.
• Solid understanding of ISO 13485:2016 and FDA part 21 CFR 820 regulations is required.
• Experience with quality investigations and CAPA management.
• Experience with Lean Manufacturing principles
• Solid understanding of Design Control and Change Control processes.
• Solid understanding of statistics and process validation principles.
• Excellent communication and problem-solving skills.
• Strong computer skills, including proficiency in using MS Office.
• Detail oriented with strong organizational and analytical skills.
• Ability to work independently and in a team environment.

Qualifications

• Ability to sit or stand for long periods of time.
• Ability to lift, bend or move up to 25 pounds.
• Ability to adjust work schedule to meet deadlines and deliverables.

Benefits

• Paid Vacation
• Paid Holidays
• Paid Sick Leave
• Partial Payment by Company of Group Health, Dental, and Vision Insurance
• 401(k) with limited company matching

Pay

$93,000 – 118,000 annually, depending upon experience

Schedule

N/A