Job Information
Integra LifeSciences Quality Assurance Coordinator in Columbia, Maryland
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.
The Coordinator, Quality Assurance reviews all batch records and quality records and ensures products and processes are compliant with all applicable regulations and Standards including but not limited to US FDA, EU, State and local regulations, ISO 13485, and Integra policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Review Pre, Post and Finished Goods batch records for completeness and accuracy.
Review and approve other assigned quality records within the QMS for completeness and accuracy.
Communicate issues related to reviewed manufacturing and quality records with the concerning departments for satisfactory resolution.
Approve manufacturing lots for QA release.
Ensure that lot specific NCs, CAPAs, Deviation are resolved prior to release of the devices.
Ensure quality records are properly scanned, filed, secured, and controlled.
Perform ERP transaction for product nonconformance, product accountability and final product release.
Assist in the initiation and investigation (including root cause investigation) of NCMR, MRB, CAPA and Deviation processes.
Perform other related duties as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience:
Bachelor’s degree in a related scientific discipline. Strong candidate with relevant experience but with lesser education is also considered.
Minimum of 2 years of experience in the medical device or similar regulated industry.
Experience with batch record review and product release.
Exceptional attention to detail
Demonstrated organizational skills.
Strong leadership and analytical skills with a team-focused attitude
Strong communication skills, both written and verbal
Knowledge of using Agile, Oracle, FaciliWorks.
Demonstrated knowledge of cGMP, ISO 13485, and other national and international regulations and standards
Computer literacy—experience with Microsoft Outlook, Word, Excel, and Access database
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of the 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. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, high precarious places, toxic or caustic chemicals, risk of electrical shock and vibration. The noise level in the work environment is usually moderate
There are no adverse working conditions associated with this position.
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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