Senior Quality Engineer

Lowell Inc. is looking for a Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will perform and lead quality engineering tasks, manage and maintain our eQMS software, and lead a team of quality engineers to ensure compliance with ISO13485:2016, FDA CFR Title 21 Section 820, and other relevant standards and regulations for the medical devices.

Lowell is the premier partner for the development and production of technologically advanced, implantable medical devices for the cardiovascular, spine, trauma and extremities markets. We manufacture components and assemblies that save lives and improve quality of life.

Senior Quality Engineer Responsibilities:- Lead the development, implementation, and maintenance of the quality management system (QMS) and related procedures and documents.- Manage the internal and external audit program, including planning, conducting, reporting, and following up on audits.- Coordinate and oversee the corrective and preventive action (CAPA) process, including root cause analysis, action plan, verification, and closure.- Monitor and analyze data using statistical methods, making recommendations for process improvement.- Manage and conduct validation activities for processes, equipment, software, and systems, ensuring compliance with regulatory requirements.- Maintain and improve the risk management processes in accordance with ISO14971 to identify, assess, and mitigate risk throughout the product realization process.- Provide training and guidance to staff on quality-related topics and best practices.- Liaise with customers, suppliers, regulators, and other stakeholders on quality matters.- Continuously improve the QMS and the quality culture of the organization.- Manage quality systems personnel.

Preferred Qualifications:- ISO13485:2016 Lead Auditor- ASQ-Certified Quality Engineer

Education/Experience:- Bachelor’s degree in engineering, quality, or related technical field- 5+ years of quality engineering experience

Knowledge, Skills, Abilities:- Proficient in leading audits, both internal and external.- Proficient in Microsoft Suite, with advanced understanding of Excel.- Proficient in Minitab or other statistical software- Strong interpersonal skills to establish and maintain effective working relationships.- Proven ability to make decisions independently.- Proven ability to coordinate new quality initiatives while maintaining daily responsibilities.- Excellent communication, analytical, and organizational skills.- Highly collaborative team player who fosters open communication.- High ethical standards.Benefits:· Lowell offers a competitive compensation and benefits package including Medical, Dental, Vision, Life Insurance, Short Term Disability, 401k Retirement Plan with 3% employer contribution, and Profit-Sharing plan. If you are a highly motivated individual with a passion for ensuring product quality, we would love to hear from you. Join our team as a Senior Quality Engineer and contribute to our commitment to excellence in medical device manufacturing.