Complaints Quality Engineer (Pittsburgh, PA)
Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
As the Complaints Quality Engineer, you will perform medical device complaint investigations and failure analysis on Smith+Nephew Robotics product.
What will you be doing?
- Lead all elements of the complaint investigation
- Perform/assign technical root cause analysis of complaints.
- Author the final conclusions of the complaint investigation and provide a summary of the investigation suitable for reporting to the end customer.
- Provide documented evidence of investigation and any conclusions established as a result of the investigation actions.
- Provide Input and Feedback to product support engineering.
- Launch corrective actions or bugs as needed to address problems causing complaints.
- Ensure that the depth of the investigation is commensurate with the triage ranking of the complaint.
- Decide the disposition of the returned product and handle the product accordingly. Update the relevant fields in the complaint management system dealing with the product after analysis is completed.
- Support global complaints team on reportable incidents to the appropriate regulatory bodies.
What will you need to be successful?
- Education: Bachelor's degree in engineering OR Associate's degree with at least two years' experience in Quality or Complaint Investigation.
- Some experience in a Quality-related/Complaint Investigation role in a regulated industry.
- Electromechanical/Software-related backgrounds are a plus.
- Basic familiarity with Medical Device standards such as, 21 CFR 820, ISO 13485, ISO/IEC 14971, etc. is a plus.
- Physical Demands: Activities of general office environment. Able to lift ~20 pounds from floor to table height. Dismantling of devices/hardware using various tools.
You Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
- Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
- Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
- Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Flexibility: Hybrid Work Model (For most professional roles)
- Training: Hands-On, Team-Customized, Mentorship
- Extra Perks: Discounts on fitness clubs, travel and more!
Smith+Nephew is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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