Job Summary: We are seeking a highly skilled and experienced Principal Quality Engineer to join our team in the medical device industry. The ideal candidate will play a pivotal role in ensuring the highest standards of quality and compliance for our medical devices. This position requires a deep understanding of regulatory requirements, quality management systems, and the ability to lead and mentor a team of quality professionals. Key Responsibilities: * Quality Management: Develop, implement, and maintain quality management systems (QMS) in compliance with FDA regulations, ISO standards, and other relevant regulatory requirements. * Regulatory Compliance: Ensure that all medical devices meet regulatory requirements and standards, including FDA, ISO 13485, and other applicable regulations. * Risk Management: Conduct risk assessments and implement risk mitigation strategies to ensure the safety and efficacy of medical devices. * Process Improvement: Lead continuous improvement initiatives to enhance product quality, reduce defects, and improve manufacturing processes. * Audits and Inspections: Prepare for and lead internal and external audits, including FDA inspections, and ensure timely resolution of any findings. * Documentation: Oversee the creation and maintenance of quality documentation, including design control, validation, and verification records. * Team Leadership: Mentor and lead a team of quality engineers, providing guidance and support to ensure the team's success. * Supplier Quality: Manage supplier quality programs, including supplier audits and performance evaluations. * Customer Complaints: Investigate and resolve customer complaints related to product quality, ensuring timely and effective corrective actions. * Training: Develop and deliver training programs for employees on quality standards, procedures, and best practices. Qualifications: * Education: Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree preferred. * Experience: Minimum of 10 years of experience in quality engineering within the medical device industry. * Certifications: Certified Quality Engineer (CQE) or equivalent certification preferred. * Knowledge: In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards. * Skills: Strong analytical, problem-solving, and decision-making skills. Excellent communication and leadership abilities. * Software: Proficiency in quality management software and tools. Pay and Benefits The pay range for this position is $70.00 - $110.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Newton,MA. Application Deadline This position is anticipated to close on May 14, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] for other accommodation options.