Advanced Quality Engineer
In this role, you have the opportunity to
As a complaint investigator, you will support MDR/adverse event reporting, triage complaint records, manage high-risk complaints to CA.
You are responsible for
- Works with a variety of diverse persons with the company such as Engineers. Field service & Application Engineers and Manufacturing personnel to Evaluates, investigates, and resolves complaints. in accordance with written procedures and global reporting requirements
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
- Completes initial assessment of reportability and escalates to manager to determine action, when necessary.
- Ensures timely medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation.
- Write and submit medical device reports (MDRs) and / or regulatory reporting.
- Provides consultation to investigator during initial check/ reportability determination
- Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion
- Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints.
- Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data got pushed to the appropriate departments for actions.
- Support reviews and audits assigned.
- Support Product Hold review, CAPA review;
- Other post market surveillance tasks.
You are a part of
The Emergency Care and Resuscitation Solutions (ECR) Post Market Surveillance Team is headquartered out of Andover, MA. We welcome you to join Philips HealthTech as a Complaints Specialist supporting ECR. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.
To succeed in this role, you should have the following skills and experience
- Education: Bachelor degree, major in engineering discipline or equivalent is preferred.
- Experience: At least 3 years of Quality and/or Regulatory experience in medical or highly regulated industries, experience in Post-market Surveillance/compliant handling is an advantage.
- Competencies and skills:
- Good command of English and Chinese Language skill is required.
- Demonstrated strong results orientation.
- Proficiency using statistical tools, office tools, and various other computer software applications.
- Must be able to work under pressure to meet regulatory reporting timeframe and company requirements.
- Be willing to work outside of normal working hours as needed to accommodate businesses in multiple time zones.
- Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment
- Requires the proven ability to consistently meet and/or exceed goals.
- Must be capable of making commitments, setting priorities, and delivering results on time.
- Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives
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 delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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.
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.