The Senior Compliance Specialist is responsible for the maintenance and integrity of documentation in support of Engineering, Manufacturing and Quality. This person must be able to work independently on most complex assignments and interface with management. Assist the PQMS Manager in resolving process or procedural related problems and priority settings. Performs all duties while maintaining compliance with FDA and ISO regulations and Respironics Quality System Requirements.
PRINCIPLE ACTIVITIES AND RESPONSIBILITIES
1. Responsible for receiving initial Engineering Change Order requests for new/revised controlled documents.
2. Responsible for researching and reviewing each request for accuracy. If a problem has been noted the Senior Compliance Specialist will request additional information from the originator and/or schedule a meeting to review submitted documentation.
3. Responsible for the maintenance and integrity of the Device Master Record, Design History File, Product History Record and Quality System documentation.
4. Responsible for reviewing and processing Engineering Change Requests (ECR) with accuracy and maintains product configuration within SAP.
5. Responsible for logging and maintenance of the CO Tracking Log, tracking it from inception through release.
6. Responsible for the creation, maintenance and integrity of the Quality System, Procedures and Forms within the Document Control System.
7. Responsible for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct.
8. Responsible for demonstrating a positive attitude and professional behavior when participating with co-workers. Proactively supports others in achieving high performance. Interactions with others must demonstrate excellent behavior flexibility and effective communications skills.
9. Ensures document and change controls are compliant with FDA and ISO regulations as interpreted by the internal Quality System Procedures
10. Serves as a team member for new product releases
1. Serve as backup support for the Document Control Department in the absence of the PQMS Manager by coordinating day to day work of Document Control in his/her absence.
2. Serve as the chairperson for the Change Control.
3. May serve as a member of the backroom support team during external audits.
4. Product configuration within SAP.
5. Provide training to internal employees.
6. Coordinate special projects within the Document Control Department
7. Create and maintain intra-department work instructions relating to Document Control
8. May perform Document Control SAP Administration tasks
1. Take the initiative to organize workload.
2. Listen and understand verbal and written instructions.
3. Detail oriented.
4. Ability to work through and resolve complex problems pertaining to Change Order processing
5. Good organizational skills.
6. Ability to set priority and work it through.
7. Ability to work under tight deadline.
8. Good communication skill and team work attitude.
9. Accuracy and speed when using expanded keyboard and data entry is required.
10. Computer knowledge of working within multi-level network platforms.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Individual must be detail oriented, accurate, well organized and able to work effectively under pressure and constant changing priorities. The employee must be able to develop and maintain positive relationships with employee population.
1. Preferred experience in FDA Quality System820.40 and ISO 13485 requirements for Document Control
2. Knowledge of ISO and QSR requirements with a preferred minimum of three years' experience in the medical device industry.
3. Strong experience on personal computers, multi-level task platforms, including use of SAP, and Document Management Systems
4. Configuration management.
5 SAP experience preferred
High School diploma or equivalent required. Bachelor's degree preferred or equivalent training, education, and/or experience in medical device industry in quality, manufacturing or engineering.
Experience a must in Reviewing and processing of Engineering Change Orders. SAP experience a plus
A little about us:
We partner with people to improve skills, teams and lives every day, and we help them achieve more than they ever thought possible.