Complaint Specialist

• Receive, log, and track complaints in a timely manner within Oracle
• Investigate complaints, including root cause analysis
• Work with a cross functional team to perform investigations including, but not limited to, Operations, Customer Service, and Engineering
• Escalation of potential reportable complaints to the Quality Manager
• Coordinate the required approvals for complaints throughout the process workflow
• Participate in continuous improvement and CAPA (Corrective and Preventive Actions)
• Support internal and external audits
• Make changes to WI, Forms, or SOPs as requested
• Send Document reviews for the required approvals at the designated intervals and ensure their timely completion
• Initiate Engineering Change Orders (ECOs) and QMS Change Orders, move COs through the workflow, and ensure proper approvals are received within Oracle

• Bachelor's degree in Life Sciences, Engineering, Quality or related field with 0-2 years of complaint handling, quality assurance, or regulatory experience
• Associate's degree in Life Sciences, Engineering, Quality or related field with 2-4 years of complaint handling, quality assurance, or regulatory experience
• High School degree with 5 years of complaint handling, quality assurance, or regulatory experience
• Experience with both medical devices and industrial products

• Knowledge of Oralce PLM preferred
• Knowledge of ISO 13485, MDSAP, FDA 21 CFR 820, and EU MDR
• Strong understanding of complaint handling systems
• Comfortable with MS Office (Word, Excel, PPT)
• Ability to take initiative; completion of tasks in an accurate and timely manner; attention to detail
• Ability to learn quickly and adapt to a fast-paced, changing environment
• Strong interpersonal skills, with the ability and willingness to interact with all people in a sensitive, responsive manner
• Excellent verbal and written communication skills; active listening skills

Why choose Nissha to build your career?

At Nissha, you can be assured that you will be part of a dynamic, diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the "General Excellence" manufacturing award from Buffalo Business First, which highlights our dedication to quality, innovation, and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires, you've come to the right place!

What we offer that you'll love...

• Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn't have it any other way.
• Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.
• Training and Development opportunities: Because we foster a culture of continuing education. Let's learn and grow together!
• Team Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.
• Retirement: We know you want to retire comfortably and we're here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.
• Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.
• Engagement Activities: Recognition isn't just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.
• Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.

And so much MORE!