Quality Engineer

Pay Range: $73,100.00 - $120,200.00

Responsible for supporting Quality Engineering requirements for change control, continuous improvement, and customer complaints handling and satisfaction. Serves as a subject matter expert and liaison between the company and customers to resolve quality and manufacturing issues and ensure positive communication channels.

Duties and Responsibilities:
- Key member of complaint and MRB investigation teams; analyze, identify, develop, and implement manufacturing/production/process improvements to improve capability and/or performance.
- Own the change control process: perform risk assessment, facilitate change control plan writing/execution, monitor implementation, and close plans timely.
- Implement and validate a new electronic Quality Management System.
- Prepare quality information and trending data for management review.
- Enable positive internal and external communication to ensure customer satisfaction.
- Participate in internal, customer, and third-party audits.
- Other duties as assigned.

Minimum Job Requirements:
- BS in Quality, Biology, Chemistry, or similar.
- 2+ years’ experience as a Quality professional in a manufacturing environment.
- Diagnostics, pharmaceutical, or biological products manufacturing environment preferred.
- Proficient in ISO 13485.
- Auditing, Six Sigma, and Lean Manufacturing experience a plus.

Knowledge, Skills, and Abilities:
- Prioritize multiple tasks effectively.
- Identify and solve problems; develop innovative solutions; act decisively with good judgment.
- Handle situations diplomatically.
- Excellent communication/interpersonal skills; strong organization; self-directed; effective at all organizational levels.
- Strong computer skills (Word, Excel, PowerPoint); Access database experience a plus.