Quality Complaint Analyst

#Change Makers

Ready to make an impact?

We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others. We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

#We Change Dentistry every day. Be part of it.

Supports and implements systems in the areas of post market surveillance, complaint handling, and customer feedback. Supports the development of and enforces internal systems and procedures to meet ISO standards, FDA quality system regulations, and other regulatory requirements.

• Receives customer complaints and review to determine validity of complaint.
• Request customer returned product and performs digital investigation.
• Collects relevant data about identified issues.
• Provide correction for customers where defects are present.
• Escalating valid complaints to the Quality Complaint Analyst II for probable cause investigation.
• Work in a team environment with members of the Post Market Surveillance group on achieving team metrics requirements.
• Work independently and with different parts of the organization to resolve complex issues.
• Identifies and assesses new opportunities for improvements to work processes.
• Able to prioritize workload to ensure maximum efficiency and customer satisfaction.
• Accurately records and reports of information as required.

• High school diploma or GED
• 1+ years of medical device manufacturing experience
• 1+ years of using Basic computer skills (Microsoft Office).

• Understanding of ISO 13485, EUDMR, 21 CFR 820, and GDP
• Documented ISO 13485 and 21 CFR 820 training
• Technical writing skills
• Ability to work with multidisciplinary teams to execute projects, investigations, and training.
• Demonstrated ability to plan and work to robust timelines
• Excellent understanding of quality principles and good documentation practices.
• Experience in investigation techniques and problem solving.
• Excellent written communication skills.

• Observe and hear warning signs and signals within all areas of the company
• Stand, walk and/or sit up to 10 hours a day with periodic breaks allowed (Standing can be up to 10 hours, Walking can be up to 10 hours, and Sitting can be up to 10 hours)
• Will be working in a fast-paced environment

• Work is performed primarily in an office environment
• The employee may occasionally be exposed to dust
• The noise level in the work environment is usually quiet to moderate
• The employee must be able to work in a fast-paced, team environment

Salary: $50,000 - $52,000

Annually. The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.

Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.

• Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!

Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.

Employment Type: Full Time

Alternative Locations: United States :
Round Rock (TX)

Travel Percentage: 0%

Requisition : 20065