Quality Engineer

Description Essential Functions

• Perform trending and analysis of customer complaint data

• Drive investigations and manage deviations and NCMRs from initiation to disposition

• Perform and lead RCAs through cross functional team involvement

• Support the development and maintenance of manufacturing quality control processes for new and existing production areas

• Support supplier quality management with respect to desk audit and quality agreement creation, execution and review via direct customer contact

• Maintain process Failure Mode and Effects Analysis for new and existing production areas

• Manage CAPA creation and ensure adequate effectiveness

• Improve existing procedures to align with cGMP and regulatory requirements

• Interpret and properly apply all applicable regulatory requirements

• Improve quality culture through site initiatives

• Review and approval of procedures, protocols, reports, etc., as required.

• Perform internal and external audits of systems and suppliers

• Filing and management of documentation when required

• Supporting other Quality System Functions

• Bachelor’s, or higher, degree in engineering or applicable science/technology program and 3+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred) OR

• Associate’s degree with 10+ years of experience in cGMP Quality Assurance (medical devices preferred)

• Effective communication, coaching/mentoring, and presenting skills

• Ability to manage change

• Self-motivated

• Independent and sound decision making capabilities

• Project management to deliver on time results

• Leadership skills / Emotional Intelligence

• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data

• Ability to travel (5-10%)

• Proficient with Microsoft Office tools, especially Excel, Word and Power Point

• Technical writing

• Statistical analysis – Minitab or other software equivalent, preferred.

• ASQ Certification (preferred)

The Quality Engineer collaborates closely with Manufacturing, Engineering, Quality Control, Facilities, Materials Management, Regulatory Affairs, Maintenance/Metrology, and site external entities (Distribution Operations, Customer Care, Quality Compliance, etc.). The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager. It is the expectation this position works during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.

The Quality Engineer will mainly work in an office environment but may also be required to work in manufacturing, warehousing, and laboratory areas.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.