Job Description
Job DescriptionCompany Overview:
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.
Position Overview:
This position reports to the Lead Quality Systems Engineer and plays a crucial role in managing and facilitating feedback processes within an organization. The role contributes to the continuous improvement of processes, products, and services within an organization.
Responsibilities:
- Manage the complaint handling process, from intake to resolution.
- Analyzing and categorizing feedback to identify patterns, trends, and common themes.
- Setting up and managing channels through which feedback can be submitted
- Review documentation for compliance and Good Documentation Practices
- Participate in product evaluations associated with field complaints.
- Ensure timely closure of complaints and maintain complete complaint documentation files.
- Facilitating prompt responses to feedback, especially when immediate action or acknowledgment is required
- Work with product-specific Quality Engineer to collect data and document investigation, and initiate Corrective Actions when required
- Sharing feedback with relevant departments, teams, or individuals who can address specific issues or identify improvements
- Creating regular reports summarizing feedback data, insights, and any actions taken or planned in response to the feedback
- Track the progress of changes or improvements made in response to feedback and ensure that they are effectively implemented.
- Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments.
- Work closely with cross-functional teams to evaluate field performance and identify areas for product improvements.
Qualifications and Skills:
- Bachelor's degree in Engineering or related field.
- Knowledge of global regulatory requirements for medical devices or pharmaceuticals, and combination products. FDA requirements for Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, and 211) is preferred
- Strong organization skills, ability to track and evaluate outstanding tasks at a large scale, prioritize multiple projects and ensure compliance with standard operating procedures
- Solid written/verbal communication and organizational skills
- Strong deduction, decision-making and critical thinking abilities
- Ability to work with cross-functional teams and to interact positively, effectively with peers, management, and customers
- Previous experience in complaint handling and processes a strong plus
- Experience developing and implementing complaint handling and PMS processes within quality management systems.
Education: H.S. Diploma or GED
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