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As the Senior Quality Engineer for a medical device manufacturer, this position is primarily responsible for assuring compliance to all regulatory requirements. This position will support Quality operations for Louisville, KY Distribution Center; NC, CAPA, inspections, audits, and complaints at a minimum.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.

• Develop, review, and approve quality records, including daily inspections, plans, protocols, and reports, supporting GxP manufacturing and development.

• Work in partnership with the 3PL to ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations.

• Perform Quality Investigations in response to quality events (complaints, HHE), use good judgement and a systematic approach to identify root cause and determine appropriate corrections, implement corrective and preventive actions, and keep good records to for traceability.

• Work with supplier quality to manage supplier controls for the finished good inspected at the LDC.

• Responsible for providing quality documentation as requested by external customers. This includes but not limited to quality certificates, as well as test reports where appropriate

• Responsible for the collection and reporting of metrics and data to Division, Facility and Department Management per defined schedules or ad hoc when required to communicate involvement and results of quality engineering activities. Responsible for reviewing data and metrics and taking or proposing appropriate action, as required. Develops creative solutions to problems as they arise.

• Other Duties as assigned.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: Bachelor’s degree in a scientific, engineering, or equivalent discipline with 7 years of experience in a regulated industry.

• Experience:

• Prior experience with Medical Devices and Instruments is required.

• Strong analytical skills, exceptional writing, and interpersonal relationship skills

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.

• Able to coordinate and lead cross-functional activities.

• Compiles and analyzes data, identifies causes, draws conclusions, generates reports.

• Uses expertise to improve operational efficiencies and meet compliance requirements.

• Demonstrated knowledge of FDA regulations, applicable medical device/quality system ISO standards, CMDR, MDD and other national and international regulations and standards.

• Knowledge of product and process design and implementation, change control, auditing, and document management systems.

• Strong statistical analysis skills.

• Solid organizational and document management skills

• Strong working knowledge Microsoft Office programs (Word, Excel, Access, PowerPoint).

• Experience working in Oracle, Agile and TrackWise systems preferred.

• Continuous Improvement experience is preferred.

• Must be able to work independently with minimal supervision.

• Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.

• Must be able to observe company policies and safety procedures at all times.

• Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.

• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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