Quality Complaint Analyst I

Straumann • Round Rock, TX

1d • $50,000 - $52,000

About The Position

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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED