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Position Summary:

This position required the person to have Knowledge with FDA regulations for Medical Devices, and ISO 13485 Medical Device-QMS-Requirements for Regulatory Purposes and any other applicable standards associated with Medical Device. This position is responsible for implementation of inspecting activities, detection of problem areas, and delivering quality inspection outcomes. In addition, they are in charge of planning and performing corrective actions if defects are found.

This position required the person to have Knowledge with FDA regulations for Medical Devices, and ISO standards and participate in regulatory inspections, and customer audits. Utilize organizational skills, to engage in team dynamics, company performance, interpersonal relationships, improvement systems and professional ethics.

Essential Duties and Responsibilities: 

• Auditing the plant processes to ensure both internal and external regulations and standards are being adhered to (e.g. FDA 21 CFR 820, ISO 13485, etc.)
• Ensuring auditing and manufacturing documentation is kept up to date.
• Review of Intech document to ensure company’s processes comply with Quality System (QS) Regulation/Medical Device Good Manufacturing Practices.
• Train new & existing employees on Intech procedures, work instructions, Policies, protocols, and documentation. 
• Support maintaining the document change control (DCN) process, customer specification notification (CSN) process, and ensure impacted employees of DCN & CSN’s are trained per requirements on training matrix.
• Supports NCR and CAPA activities through product non-conformance control including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework.  Analyzes the data for the reasons of Quality Improvement and reporting.
• Be proficient in the complaint handling process through review of data, trend evaluations, and investigations associated with product and customer complaints.   Analyzes the data for the reasons of Quality Improvement and reporting.
• Actively track CAPA’s and Complaints as needed and remain diligent to ensure the tasks are completed on time. As needed, assist team in developing solutions to problems and offer possible improvements to processes and systems.
• Supports the management of the day to day operation and responsibilities of document control to ensure that all users have the latest revision of appropriate Bradshaw Medical documentation: operating procedures, work instructions, forms, customer: quality agreements, prints, specifications, any additional documentation. 
• Manage a schedule for periodic review of QMS documentation, review, effective (implementation) dates to ensure documentation remains current with regulations, standards and business needs.
• Ensure personnel within areas of responsibility are competent to perform new tasks and continuity of same; evaluates training needs on a regular basis, but at least annually
• Maintain the internal training program and training matrix(s) by ensuring all employees are trained to the current revisions of QMS documentation per the individual job descriptions, including roles and responsibilities. 
• Support Risk Management activities including data preparation for annual product risk file review, management and preparation of event-based reviews, review and coordination of quality activities related to risk matrices.
• Responsible for scheduling and conducting internal audits and leading and managing supplier audits, monthly supplier performance evaluations, and supplier corrective actions
• Assist in preparations for internal and external audits.   Participate in audits as needed.   Support external regulatory audits as needed. 
• Assists with supplier relationship and acts as the key escalation point for Intech QMS. 
• Assist in preparing, conducting, evaluating and facilitating quality related training programs for employee’s base on the training needs and certification requirements.
• Provides support to Quality Management personnel and perform other duties as assigned.
• Collaborates with other departments to meet customer requests.
• Support accuracy metrics through identification and documentation of case handling errors.  

Knowledge, Skills & Competencies:

• Minimum of 5 years of experience with medical device quality management system i.e. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes and FDA 21 CFR Part 820 Quality System Regulation (QSR) requirements.
• 2+ years of experience in quality auditing for medical device or pharmaceutical companies. 
• Knowledge of Medical Device Risk Management Regulation ISO 14971. 
• Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization.
• Advanced knowledge and experience of the CAPA and complaint process in a medical device manufacturing facility.  
• Experience with content management/quality systems, archiving and control techniques. 
• Communication: ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans.
• Strong problem solving, critical thinking and analytical skills.
• Ability to drive decisions, as well as the ability to make independent decisions with minimum oversight.  
• Ability to work in a team environment, as well as, autonomously.
• Capable of handling stressful situations.
• Excellent verbal and written communication skills.
• Detail oriented and organizational skills.  
• Willingness to accept new assignments and projects pertaining to different areas or products. 
• Ability to read and comprehend complex instructions.
• Ability to maintain a sense of urgency and ability to prioritize workload. 
• Ability to effectively manage projects.
• Computer literate in various software applications (i.e. Microsoft Office).        

Work Environment: 

• The work environment consists of time spent in both an office and manufacturing environment.  
• The noise level in the work environment is usually moderate.
• The noise level in the work environment is usually moderate.
• Work environment consists of time spent in both an office and manufacturing environment. 
• Includes potential exposure to sounds and noise levels that can be distracting or uncomfortable.
• Includes potential exposure to moving mechanical parts. 
• Includes potential exposure to coolants and oils. 
• Work environment is temperature controlled.
• Travel as required for the position.  

The work environment described here is representative of that which an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Job Requirements:

• While performing the duties of this job the employee is regularly required to sit, stand walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear.
• The employee must be able to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
• The employee must be able to sit for up to 10 hours per day.
• Ability to function in highly stressful situations. 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Education, Certifications, and/or Licenses Requirements: 

• Bachelor’s Degree (Life Sciences Preferred) or equivalent experience. 

EXALTA is an Equal Opportunity Employer. We respect every employee as an individual, and we hire and promote based on qualifications, performance, and potential - without regard to race, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.