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- Tasks: Lead complaint evaluations and ensure compliance with FDA regulations in a fast-paced medical device R&D environment.
- Company: InnoTECH Staffing connects talent with innovative companies in the medical device industry.
- Benefits: Onsite work with opportunities for professional growth and collaboration in a dynamic team.
- Why this job: Make a direct impact on product quality and safety while working with cutting-edge technology.
- Qualifications: 4-year engineering degree or equivalent experience in biomedical engineering and complaint handling.
- Other info: High visibility role with potential leadership opportunities in a supportive team environment.
The predicted salary is between 48000 - 72000 £ per year.
Job Description
InnoTECH Staffing is looking to hire a Lead Complaint Handling Engineer for 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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Lead Complaint Handling Engineer - QMS, medical device R&D employer: ZipRecruiter
Contact Detail:
ZipRecruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Complaint Handling Engineer - QMS, medical device R&D
✨Tip Number 1
Familiarize yourself with FDA regulations and Quality Management Systems (QMS) relevant to medical devices. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Highlight your experience with complaint handling investigations and product analysis in your discussions. Be prepared to share specific examples of how you've successfully navigated complex complaints or improved processes in previous roles.
✨Tip Number 3
Showcase your problem-solving skills by discussing any challenges you've faced in a cGMP environment. Employers value candidates who can think critically and adapt to fast-paced, changing situations.
✨Tip Number 4
Network with professionals in the medical device industry, especially those involved in complaint handling and quality assurance. Building connections can provide insights into the company culture and may lead to referrals.
We think you need these skills to ace Lead Complaint Handling Engineer - QMS, medical device R&D
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Lead Complaint Handling Engineer position. Understand the key responsibilities and required skills, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in complaint handling, particularly in a cGMP environment. Mention specific projects or situations where you successfully managed product complaints or contributed to quality management systems.
Showcase Technical Skills: Demonstrate your knowledge of FDA regulations and Quality Systems in your application. If you have experience with SalesForce or technical writing, be sure to include that information, as it is crucial for this role.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your enthusiasm for the role. Discuss how your background aligns with the company's mission and how you can contribute to their success in the medical device industry.
How to prepare for a job interview at ZipRecruiter
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with complaint handling and quality management systems in detail. Highlight specific examples where you successfully navigated FDA regulations or improved processes in a cGMP environment.
✨Demonstrate Problem-Solving Skills
Expect questions that assess your problem-solving abilities. Prepare to share instances where you identified a quality issue and the steps you took to resolve it, emphasizing your analytical thinking and decision-making process.
✨Communicate Effectively
Since this role involves cross-functional collaboration, practice articulating complex information clearly and concisely. Be ready to explain how you would present complaint data to different stakeholders, ensuring you can adapt your communication style as needed.
✨Prepare for Behavioral Questions
Anticipate behavioral interview questions that explore your teamwork and leadership skills. Think of examples where you led a team or contributed to a project, focusing on your ability to maintain positive communication and cooperation with colleagues and external partners.
