Sr. Compliance Specialist
Source: beBee S2
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.Â You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
You are responsible for
- Responsible for receiving initial Change Order requests for new/revised controlled documents. Responsible for researching and reviewing each Change Order request for adequacy and accuracy.Â 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.
- Responsible for the maintenance and integrity of the Device Master Record, Design History File, Device History record and Quality System documentation.
- Responsible for reviewing and processing Engineering Change Requests (ECR) with accuracy and maintains product configuration within SAP. Responsible for logging and maintenance of the CO Tracking Log, tracking it from inception through release.
- Responsible for the creation, maintenance and integrity of the Quality System, Procedures and Forms within the Document Control System.
- Â Responsible for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct
- Responsible for demonstrating a positive attitude and professional behavior when participating with co-workers.Â Proactively supports others in achieving high performance.Â Interactions with others must demonstrate excellent behavior flexibility and effective communications skills. Ensures document and change controls are compliant with FDA and ISO regulations as interpreted by the internal Quality System Procedures Serves as a team member for new product releases
- The Senior Compliance Specialist is responsible for maintenance and integrity of documentation in support of Engineering, Manufacturing and Quality Change Orders.
- 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, EU, and ISO regulations and local Quality System Requirements.
You are a part of
The Philips Hospital Respiratory Care business products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.Â Â We believe that by understanding our customers' problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
To succeed in this role, you should have the following skills and experience
- 2+ years related experience in Change Control/Change Management
- Familiarity with Document Management systems/repositories
- Experience in medical device industry in quality, manufacturing or engineering.
- Preferred â" Knowledge of FDA regulations & regulatory requirements
- Bachelor's degree preferred, or equivalent related experience
- Â 2+ years of professional experience in Medical Device or similar regulated industry
- Excellent communication, organizational, and project management skills
- Successful experience working with cross-functional teams across multiple work locations
- Network oriented and able to interact with different business functions and can work within numerous systems
- Work cooperatively in a team environment
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you
Experience working in an organization committed to the improvement of people's lives. The opportunity provides you the opportunity to work within an energetic, genuine, inventive, supportive, and dynamic team atmosphere, healthy work-life balanced environment, and a management team fully committed to your personal and professional career development. We will be the best place to work for people who share our passion, work ethic, and commitment to continuous improvement.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by deliverng innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
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