Reference #: be19b90f-6733-43dc-b4b2-7716a5133c7a
Description
DESCRIPTION/JOB SUMMARY
To help develop, execute, and maintain a compliant, lean, and effective Quality Management System
RESPONSIBILITIES/DUTIES
*Analyze Returned Products and create reports that will be filed with the United States Food & Drug Administration (US FDA) (electronic Medical Device Registrations - eMDR's)
*File eMDR reports to the US FDA automated systems (E-Submitter and WebTrader)
*Act as Independent Reviewer to ensure product design and development stages meets FDA requirements in relation to Design History Files (DHR's) including Risk Assessments
*Review Engineering changes to ensure compliance/conformance to specifications and processes
*Serve as Internal/Supplier auditor under the direction of the Director of Quality/Quality Manager Representative (QMR)
*Issue and process Corrective or Preventive Actions based upon identified nonconformities
*Create and maintain Device Master Records for design validation in production environments
*Maintain current databases to ensure functionality and data integrity
*Assist with the execution of the 510(k) Approval process with the FDA which allows for medical devices to be marketed
*Establish Unique Device Identification (UDI) and Device Listings with the FDA for Medical Devices
*Create Excel based reports upon request
*Ensure all safety and security rules are strictly observed and any accidents, incidents or injuries are promptly reported to management
*Attend the Annual C-TPAT Security Training
*Focus on continuous improvement, and consistently demonstrate good business judgment
*Work effectively with all Pride departments to exceed internal and external expectations
*Pride retains the discretion to modify duties and/or assign other duties as necessary
REQUIRED SKILLS
*Must be a team player, friendly, professional, detail-oriented, and honest
*Must be a change agent and champion for continuous quality improvement
Must have the ability to:
*Multi-task, problem-solve, and prioritize in a fast-paced working environment
*Work and communicate effectively with multiple departments as a cross functional team
*Be extremely detailed-oriented
*Be a quick learner and adaptable to learning new tasks and skills
*Be flexible as hours may vary based on business needs
*Carry out duties with the utmost integrity
*Lift/push/pull 40lbs
Must have:
*Relentless drive to achieve advancement and continuous improvement
*Basic working knowledge of Microsoft Office Word, Excel and PowerPoint
*Excellent web navigation skills
*Excellent presentation, verbal, and written communication skills
*Creative problem-solving skills
*Strong organizational skills to schedule tasks and develop realistic action plans while being sensitive to time constraints and resource availability
*Basic statistical, root cause, and failure analysis skills
PREFERRED SKILLS
*Basic working knowledge of Microsoft Access preferred
*Advanced working knowledge of Microsoft Office Word, Excel, PowerPoint, and Access, including the ability to write macros preferred
REQUIRED EXPERIENCE
*No experience required
PREFERRED EXPERIENCE
*At least 1 year of hands-on experience in manufacturing, pharmaceutical, or engineering disciples preferred
*At least 1 year of experience in quality management systems including ISO 13485 or equivalent preferred
*Current or previous successful employment experience with Pride Mobility Products Corporation preferred
REQUIRED EDUCATION
*Bachelor's Degree in an Engineering or technical related field
PREFERRED EDUCATION
*Bachelor's Degree in Computer Science, Electrical Engineering, or a related field preferred
*American Society for Quality (ASQ) Certification or a similar certifying body in Quality Systems preferred
*Six Sigma Green or Black Belt preferred
DETAILS
*This job description is not intended to be all-inclusive
*In exceptional circumstances, some of the physical requirements of this position may be modified or eliminated as a reasonable accommodation for a person with a disability as defined by the Americans with Disabilities Act
If you are a person with a disability, a disabled veteran, or require a reasonable accommodation or assistance in completing an application for employment, please contact our human resources department at 1-800-800-8586 x1250.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Pride Mobility Products®/Quantum Rehab® is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected Veteran status, age, or any other characteristic protected by federal, state, or local law.
