Danaher Corporation Post Market Surveillance Specialist in Mahwah, New Jersey
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.
The Post Market Surveillance Specialist is responsible to investigate, complete, and maintain Nobel Biocare Complaint Records in timely and accurate manner in accordance with the FDA's QSR Regulations, ISO 13485, the MDD and departmental requirements as appropriate. The incumbent will also evaluate incoming data to determine if sufficient information is available to understand the nature of the complaint and initiate an investigation. Investigations will be sorted by product line, complaint type, and root cause for Review and Reporting. Additionally, this position will maintain customer complaint data and files in support of internal and 3rd party audits.
The position holder needs Medical Device Complaint Handling experience and Post Market Surveillance knowledge. He/she must also be:
- Accountable for setting own work direction and completing work tasks
- Able to manage the end to end process of customer complaints including utilization of the database systems used to process complaints
- Able to fill out Medical Device Reports (MDR) decision trees when needed, after sufficient information is available and after Manager of Quality Control reviews and approves
- Contribute to the business-wide quality strategy and quality objectives
- Maintain systems to monitor and facilitate the timely investigations and close out of open complaints. Ensure complaints are investigated and completed in a timely manner
- Monitor and communicate significant complaint trends, adverse events and other pertinent reports
- Provides and analyzes organizational quality metrics as required to assess the effectiveness of quality system improvements.
- Provide internal awareness of noted trends and complaint issues via periodic and ad-hoc reports as required by the business unit/platform team.
- Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary
- Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.
* Bachelor’s degree in relevant science with 5 years of experience in a medical device regulatory industry. * Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001 is highly preferred. * Experience using computer based analytical, statistical and modeling tools to identify and improve processes, must be proficient in excel, and be able to quickly develop proficiency in SAP complaint handling systems. * Strong analytical, deductive reasoning and listening skills are required. * Must be able to communicate precisely and accurately to all levels of the organization * Ability to work independently but with a large sense of collaboration and cooperation to exchange within the team in order to always sustain results and work progresses. * Ability to act as a liaison across functions and with outside customer representatives or stakeholders concerning operational or project schedules/deliverables, audits, etc. * Experience with analyses of product development and manufacturing engineering. * Working knowledge of reading and interpreting product specifications is preferred.
/Nobel Biocare is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law./
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-NJ-Mahwah
Req ID: NOB002037