Lead Complaint Handling Engineer - QMS, medical device R&D

Job Description

InnoTECH Staffing is looking to hire aLead Complaint Handling Engineerfor a client in the Manchester, NH area.
This requires being onsite 5 days a week.
There is no sponsorship.

The Lead Complaint Handling Engineer will work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager and is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:

• Responsible for reviewing complaints that involve a potential quality problem with a medical device.
• Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge.
• Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations and other regulatory requirements.
• Identify and make sound decisions regarding medical device reporting to regulatory agencies.
• May lead a small team of Complaint Handling Engineers.
• Create procedures and work instructions.
• Increase efficiencies through process improvements.
• Develop product training programs.
• Generate reports to track and trend complaints across product lines.
• Present complaint data cross-functionally.
• Work with failure analysis team to improve product investigations related to complaints.
• Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.
• Participate in audits and CAPA investigations as they relate to complaint handling.
• Contribute independently while also collaborating with other team members and departments needing product complaint information.
• Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
• Serve as a subject matter expert on complaint handling.
• Perform other related duties as assigned under management supervision.

Skills needed to be successful:

• 4-year engineering degree, preferably in biomedical engineering, and 3+ years relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis; OR 2-year degree and 5+ years relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211).
• Experience with SalesForce.
• Good problem-solving and proficient computer skills are required.
• Solid written/verbal communication and organizational skills, as well as attention to detail.
• Sound technical writing skills.
• Excellent time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.
• Ability to work well independently and on cross-functional teams in a fast-paced, changing environment.
• Motivated self-starter with a strong desire to see individual tasks through to completion, and to help as needed to achieve team goals.

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