The company is looking for a professional to improve product quality and manage customer feedback and CAPA processes.
Requirements
- Direct experience working with ISO 13485, ISO 9001, and 21CFR820 required.
- Proficient with Microsoft tools (Word, Excel, PowerPoint, Visio, Teams) and MiniTab.
- Ability to analyze and process data and draw appropriate conclusions.
- Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
- Understanding of plastics materials, properties, manufacturing processes, and product assembly.
- ASQ certification is desired.
Responsibilities
- Lead cross-functional team members supporting the Customer Feedback/Complaint Handling Process and CAPA process.
- Monitor product quality improvement to ensure execution of actions, including any resulting customer communications/interactions.
- Complete Risk and Impact Assessments.
- Drive product and process changes to improve product quality.
- Apply problem-solving tools (8D, 5-whys, cause and effect, etc.).
- Demonstrate strong root cause/corrective action skills.
Other
- 5 years of experience in an Engineering, Quality, or Regulatory capacity required (preferably within the medical device, biotech, or pharmaceutical sector)
- Strong analytical, problem-solving, and teamwork skills.
- Excellent written and verbal communication skills.
- Experience prioritizing conflicting demands.
- Excellent interpersonal, organizational, and influencing skills.
