Quality Engineer II
Quality Engineer II
Posted on :
05-04-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
How will you make an impact
The Quality Engineer II will lead investigations development of investigation plans and assist in development of corrective action plans of quality issues related to customer complaints corrective action requests and quality improvement requests. Communicate with customers regularly to ensure products meet expectations.
What will you do
- Lead multifunctional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process.
- Lead multifunctional team members supporting internal investigations (NCM UD) & CAPA process
- Monitor product quality improvement to ensure of actions including any resulting customer communications/interactions.
- Complete Risk and Impact Assessments
- Interface directly with customers and internal groups.
- Develop realistic solutions to meet customer needs and solve problems
- Strong Root Cause / Corrective Action skills.
- Drive product and process changes to improve product quality.
- The ability to perform independently and as part of a team.
- Must be able to influence and negotiate with people and resolve issues.
- Communicate recommendations and decisions across the organization.
- Experience with problem solving tools 8D 5whys cause and effect etc).
- Demonstrated ability to lead in a fastpaced technical environment absorb technical information review technical information and make technical decisions.
How will you get here
- Minimum requirements: HS Diploma and 5 years direct Quality Engineering experience.
- Higher education preferred
- 2 years experience in medical device biotech or pharmaceutical industry in an Engineering Quality or Regulatory related role required.
- Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820 required.
Knowledge Skills Abilities
- Strong analytical problem solving and teamwork skills are required.
- Experience at effectively communicating complaints risks production process controls Corrective and Preventive Action (CAPA) and improvements.
- Ability to analyze and process data and draw the appropriate conclusions.
- Demonstrated knowledge of Quality Management System tools continuous improvement methodologies indepth understanding of products and processes
- Understanding of plastics materials properties manufacturing processes and product assembly.
- Experience prioritizing conflicting demands
- Excellent interpersonal organizational and influencing skills
- Ability to analyze and process data and draw the appropriate conclusions
- Experience working with multifunctional teams and facilitating teams to identify and implement solutions to complex problems
- Excellent communication written and presentation skills. Proficient with Microsoft tools; Word Excel Power Point Visio Teams; MiniTab.
- ASQ certification is desired.
Employment Type
Full-Time
Key Skills
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