Duties & Responsibilities
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
- Assures that complaint management, including appropriate response to risks, adverse event reporting decisions, and collection and documentation of complaints data.
- Assures that timely responses regarding product complaints are provided to customers and Regulatory Authorities.
- Actively contribute to making better products and bolstering positive relationships with Regulatory Authorities.
- Receive, document, and respond to Smiths Medical product complaints according to global regulatory requirements, and Smith Medical SOPs:
- Process product complaint samples for investigation.
- Maintain complaint records.
- Coordinate internal complaint investigations to ensure completion in a timely manner.
- Use judgment to analyze adverse incidents and determine if events must be reported to Regulatory Authorities.
- Communicate with customers to gain information for complaint investigation and to convey investigation results.
- Support site in internal and external audits, as they relate to global product complaints.
- Remain current on Smiths Medical product-related issues and trends.
- Prepare reports and make recommendations regarding adverse complaint trends, the results of complaint investigations, and problem solving activities.
- Actively engage in providing input on process improvements.
- Escalate relevant product complaint issues through the appropriate Quality manager, and management, as necessary.
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
- Other duties as assigned by supervisor.
其他主管布置的任务。Diversity & Inclusion
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.The Individual
Education and Experience
l University Degree (BA degree) and major in electronics preferred
l Medical device work experience, above 5 years and powered medical device preferred.
l Prefer at least 3 year experience working with product complaints in a medical device company with medical claims or equivalent
Technical Knowledge and Skills
l Required: Proven experience in quality assurance or quality control in a medical device or similar regulated environment.
l Required: Proven experience on medical device complaint handling
l Required: Knowledge of GMP/ GDP requirements and previous database management and analysis experience is required.
l Knowledge of and expertise in the use of personal computers for spreadsheets (Excel), communication and scheduling (Outlook), word processing (Word), and various databases (Oracle, SharePoint)
l Accurate and professional verbal and written communication and presentation skills and written English is required.
l Ability to understand regulatory requirements and how they impact Company response to customers.
l Ability to understand and gather the information necessary to troubleshoot technical problems with medical products.
l Ability to work independently with minimal supervision.
Planning and Decision Making
l Self schedule day to day planning.
l Able to think quickly and use initiative in resolution of customer complaints.
l Reactive to directives from supervisor.
At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.About Smiths Medical
Smiths Medical is always looking for people with a passion to positively impact the health and wellbeing of people around the world. If you have a curious mind, relish a challenge and want to make a difference then bring your talents here and your opportunities are endless. We're proud that we've been helping propel the human world forwards during our 160-year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big we have introduced some of the most trusted brand names in healthcare. Today we're an aligned global business 8,000 colleagues, that touches the lives of 7 people every second across the globe. So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.
Apply on company website