Quality Engineer II

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2 days ago Be among the first 25 applicants. How will you make an impact?

The Quality Engineer II will lead investigations, develop investigation plans, and assist in developing corrective action plans for quality issues related to customer complaints, corrective action requests, and quality improvement requests. Communicating with customers regularly to ensure products meet expectations is also part of the role. Work Schedule

Standard (Mon-Fri) Environmental Conditions

Office What will you do?

Lead multi-functional teams supporting the Customer Feedback/Complaint Handling Process & CAPA process.

Support internal investigations (NCM, UD) & CAPA process.

Monitor product quality improvements and ensure execution of actions, including customer communications.

Complete Risk and Impact Assessments.

Interface directly with customers and internal groups.

Develop solutions to meet customer needs and resolve problems.

Apply strong Root Cause / Corrective Action skills.

Drive product and process changes to improve quality.

Work independently and as part of a team.

Influence, negotiate, and resolve issues effectively.

Communicate recommendations and decisions organization-wide.

Utilize problem-solving tools (8D, 5-whys, cause and effect, etc.).

Lead in fast-paced technical environments, review technical info, and make decisions.

How will you get here?

HS Diploma and 5 years of direct Quality Engineering experience.

Higher education preferred.

At least 2 years experience in medical device, biotech, or pharmaceutical industry in an Engineering, Quality, or Regulatory role.

Experience with ISO 13485, ISO 9001, and 21CFR820 required.

Knowledge, Skills, Abilities

Strong analytical, problem-solving, and teamwork skills.

Effective communication of complaints, risks, controls, CAPA, and improvements.

Data analysis and conclusion drawing skills.

Knowledge of Quality Management System tools, continuous improvement, and product/process understanding.

Understanding of plastics materials, properties, manufacturing, and assembly.

Prioritization skills.

Interpersonal, organizational, and influencing skills.

Experience with multi-functional teams and solution facilitation.

Excellent communication and proficiency in MS Office and tools like MiniTab.

ASQ certification is desirable.

Additional Details

Seniority level: Not Applicable

Employment type: Full-time

Job function: Quality Assurance, Product Management, and Engineering

Industries: Pharmaceutical Manufacturing and Biotechnology Research

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Permanent