Quality Engineer

The Quality Engineer is accountable for support of the continued development, improvement and implementation of the Quality System. This position actively participates in quality guidance, product resolution decisions and problem-solving techniques for process improvement and continuous improvement activities. The Quality Engineer defines, executes, monitors and supports QA/QC related project activities for new product development, sustaining engineering and acquired products such as quality plans, product acceptance criteria and performing lot release. This position will be responsible for supporting and/or leading investigations into CAPA’s, Complaints, NCR’s, SCAR’s, internal audits, receiving inspection, etc., and work closely with all functions within the company.

The ideal candidate is a self-motivated individual eager to learn. The Quality Engineer works with a cross-functional product team to provide Quality support and oversight to outsourced supplier/manufacturing activities.

Primary Responsibilities:

• Responsibilities include but are not limited to:
• Leads the work on moderately complex problems including analysis of data, root cause analysis and design of experiments.
• Ensures regulatory requirements and process/product goals are met across all projects.
• Supports Quality Systems such as delivery holds, internal and external audits, CAPA and investigations. Assists in creation and management of changes to specifications, batch records, process requirements, and nonconformance reports.
• Leads customer complaint investigations related to design and manufacturing related issues
• Works creatively and analytically in a problem-solving and process-oriented environment. Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
• Prepare trending reports to promote corrective action and continuous improvement.
• Assists in the qualification, setup, monitoring and change management of suppliers for the procurement services/goods/raw materials including supplier evaluations and supplier CAPA investigations.
• Acts as the Quality SME for new product development projects.
• Other duties as assigned.

Minimum Qualifications:

Education:

• BS degree in Engineering or equivalent.

Experience:

• 3-5 years of relevant experience, preferably in the medical device industry.

Competencies:

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
• Proficient in SPC tools and techniques
• Excellent oral and written communication skills, including strong technical writing expertise;
• Must have experience in protocol development, execution and reporting for equipment qualifications (IQ/OQ/PQ), processes and system validations.
• Experience with leading cross functional teams as the quality expert
• Thorough understanding and prior experience working in an FDA regulated environment.
• Knowledge of, EU MDD/MDR, ISO 13485, 21CFR820 and ISO 14971 highly preferred;