Job Information
Integra LifeSciences Quality Engineer II in Sparks, Nevada
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION
As the 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 Reno Distribution Center; CAPA, inspections, audits, and complaints at a minimum.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Work in partnership with the 3PL to insure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations
Develop, review, and approve quality records, including daily inspections, plans, protocols, and reports, supporting GxP manufacturing and development.
Perform Quality Investigations in response to quality events (complaints, HHE), use good judgement and a systematic approach to determine appropriate corrections and root cause(s), implement corrective and preventive actions, and keep good records to ensure accurate event reconstruction.
Responsible for providing quality documentation as requested by external customers. This includes 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
DESIRED MINIMUM QUALIFICATIONS
Education: Bachelor's degree in a scientific, engineering, or equivalent discipline with 5+ years of experience in a regulated industry.
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.
Recognized as a leader within the team.
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, EUMDR 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.
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.
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, and mobile phone as well as other general office equipment. Strong computer skills are required.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. Must be capable of using a keyboard for computer purposes.
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.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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