Quality Assurance Specialist

Would you like to work in an international environment where you’ll make a difference every day? At Permobil, we’re looking for game-changers to join us as we innovate for individuals and develop the world’s most advanced assistive solutions.

At Permobil, the people who use our products come first. Our purpose is to create advanced assistive solutions that make the lives of adults and children living with disabilities more enriching.

Our people are passionate about pushing the boundaries of technology to deliver innovations that improve lives. We are a sustainable and responsible business committed to continuous improvement, and our customers can trust us to provide market-leading solutions driven by insights-based clinical data.

The QualitySpecialist supports the Quality Management System by ensuring compliance withregulations, recognized standards, and company processes.

This position’s primary focus is post-marketsurveillance data analysis, including customer feedback, complaints, and adverseevents.

They also initiate and driveimprovements and support other key processes such as corrective and preventiveactions, audits, and change management.

INVESTIGATESCUSTOMER COMPLAINTS BY :

Using variousmethods of obtaining information on a complaint, including but not limited to reviewingcomplaints documented by Customer Experience, researching customer history,reviewing manufacturing information, interviewing customers, and reviewingevaluation results on returned product.

ENSURES REGULATORY REQUIREMENTS ARE MET BY :

• Understanding regulatory requirements related to complaintsand adverse events in markets where the products are sold, including timeframesfor investigations and reporting;
• drafting and maintaining procedures relatedto complaint handling, investigations, and reporting; reviewing complaintinvestigations and presenting recommendations on reporting requirements to theGlobal Complaint Committee or management;

working with R&D to updateproduct risk management files; and writing and submitting reports to regulatoryauthorities within the required timeframe.

IMPROVES Product Performance BY :

• Analyzing post-market data collected usingspreadsheets, graphs, basic statistics, or other analysis techniques; reportingon results in a meaningful way including graphs, images, and summaries asappropriate;
• communicating results to Quality Assurance / Regulatory Compliance (QA / RC)Department Management, Quality Engineers, and other groups via email andnarratives, reports, and virtual and in-person presentations;

creating reportsto support risk management and clinical evaluations; and proposing improvementactions, including corrective and preventive actions based on the data analysis.

PROMOTES accurate RECORDSby :

Reviewing / auditing complaint records forcompleteness; working with Customer Experience to correct errors; communicatingbest practices for documentation practices and record keeping, proposingsystem, process, and form improvements.

SUPPORTS THE BUSINESS BY :

Reporting to thesite Quality Management Representative; accomplishing miscellaneous duties asneeded to maintain the safest working environment, maintain the aspects ofconfidentiality, and maintain or enhance the performance of this position, theQA / RC department, and the company;

performing special assignments such as auditing,data analysis, and documentation.

Maintainssafe and clean work environment by :

Operatingall machinery in a safe and efficient manner; reporting any safety hazards toassigned supervisor or safety manager;

complying with all safety and qualitypolicies, practices, and procedures.

MAINTAINS QUALITY SERVICE BY :

Keepingerror rates minimal and within acceptable ranges.

Contributesto team effort by :

Performing additional tasks or duties as requested by siteQuality Management Representative; performingspecific tasks to support new product launches / product changes and CAPA;

maintaining a good attendance record; accomplishing related results as needed.

MaintainsPROFESSIONAL AND technical knowledge by :

Attendingeducational workshops, seminars, and conferences; reviewing professionalpublications; establishing personal networks.

Requirements :

Mandatory : Sufficient experiencewith successfully and independently performing project tasks requiring datagathering, curation, analysis, and presentation to be able to perform tasksindependently with minimal guidance.

Demonstrated ability to work in a collaborative work environment and tolead and continually improve processes.

Preferred : Bachelor’s Degree fromcollege or university with a minimum of two years related experience, or anAssociate’s Degree from college or trade school with a minimum of five yearsrelated experience.

Why Permobil is a great next step for you!

1.You’ll make a difference. Every day

Everything we do leads to understanding and improving the lives of our users. Through our evidence-based innovation, we make a difference to people’s lives.

2.You’ll make your mark as part of our future

We collaborate with colleagues across borders to Innovate for Individuals. The impact you make personally could lead change around the world.

3.You’ll feel welcome from day one

We’re known for being great colleagues, who are collaborative, fun and at the cutting-edge. Everyone in the Permobil family cares as much as you do about making a positive difference.

4.You can have a lifestyle you love

Who you are

You are passionate, innovative, and ambitious.You want to make a difference for others and feel fulfilled when you can seethe link between the work you do and positive improvements in the lives ofothers.

You search out opportunities and are prepared to go off the beatentrack to chase your dreams. You don’t follow the herd you find new ways ofworking and go where you see potential to make your mark.

You are a pioneer, arevolutionary, a game-changer and you are who we’re looking for.

Last updated : 2024-05-29