Senior Quality Engineer

Laborie Medical Technologies Corp•Portsmouth, NH

13d

About The Position

The Senior Quality Engineer serves as a site- or product-specific subject matter expert and mentor for junior team members. The role ensures technical regulatory and quality requirements are met within the Quality Management System and throughout the product life cycle, while driving strategic quality initiatives and compliance with high standards. The engineer provides leadership and expertise to the Quality Engineering function; develops validation strategies; leads nonconforming product investigations and dispositions; and supports design and development of new or modified products and processes, including design transfer. The role manages regulatory and quality projects with external agencies and test laboratories, represents Quality in change-order and deviation reviews, plans product and process monitoring and measurement, investigates product and process changes, and handles complaint- and service-related investigations. Additional responsibilities include applying current medical-device QSR and ISO requirements, using statistical techniques and trending to identify potential corrective or preventive actions, initiating and resolving corrective and preventive actions, collaborating with design personnel, recommending and implementing improvements, performing risk analyses, and maintaining Risk Management Files for assigned Laborie products.

Requirements

At least 8 years of experience in technical medical-device quality and compliance roles with a bachelor's degree in engineering or a related scientific field, or at least 6 years of such experience with a master's degree in engineering or a related scientific field.
Ability to write clear, concise, and effective reports and procedures; learn quickly with guidance and training; and work with minimal direct supervision.
Computer literacy and experience with spreadsheet, database, and word-processing applications.
Processing and product-evaluation experience.
Knowledge of Quality System Regulation (CFR 820) and ISO requirements.
Ability to establish and maintain effective working relationships with manufacturing and technical personnel at all levels.
Strong project-management and organizational skills.
Proven leadership track record.
Excellent communication and problem-solving skills.
Strong conflict-resolution skills.
Proficiency in quality tools.
Experience with risk management.

Nice To Haves

Experience with ISO 14971 risk management is preferred.
Lead auditor certification is preferred.
ASQ certification is preferred.
Lean Six Sigma training is preferred.

Responsibilities

Provide leadership and subject matter expertise to the Quality Engineering function and mentor less experienced Quality personnel.
Develop strategies for validating manufacturing processes, test methods, and quality processes.
Lead nonconforming product investigations, disposition, and approval using documented root-cause analysis techniques.
Lead and support design and development activities for new or modified products and processes, including design transfer.
Manage regulatory and quality projects with external agencies and test laboratories to ensure appropriate certification and testing.
Represent Quality in the review and approval of proposed change orders and deviations, determining effects on materials, products, and processes.
Develop, plan, and perform product and process monitoring and measurement activities.
Investigate proposed process and product changes to ensure continued safety and quality.
Perform investigations related to complaints and service.
Maintain knowledge of current QSR and ISO requirements applicable to the medical device industry.
Develop and institute statistical techniques and trending to identify potential corrective or preventive actions.
Initiate, plan, and perform corrective and preventive actions, and ensure their timely resolution.
Collaborate with design team personnel in developing new products using engineering skills.
Recommend and implement process and product changes and improvements.
Validate manufacturing processes, test methods, and quality processes as requested.
Perform and document risk analyses and make decisions based on risk-management principles.
Maintain the Risk Management File for assigned Laborie products.