Job Description Summary

The Sr. Complaint Investigation Specialist role is responsible for investigational activities relating to Dispensing Solution devices. This role supports the daily activities of technical staff in an assigned area. Receives priorities from the team supervisor to perform assigned task to completion. Has substantial knowledge of work processes and tools within own area. Applies knowledge to solve standard and non-standard problems within own area. This role will be accountable to ensure that MMS Dispensing complaints comply with MDSAP and FDA (or primary regulations of their respective countries) through the implementation of an effective investigational process.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Duties & Responsibilities

• Demonstrates expert knowledge of Dispensing products, how products are used, as well as how they are serviced.

• Ensures complaint investigation findings are provided to appropriate personnel in a timely manner and escalates to Management critical issues as necessary.

• Key contributor on projects that drive product safety, product quality, and customer satisfaction.

• Ensures complaint investigation documentation and records are complete and in compliance with regulatory requirements. May support or oversee other less experienced colleagues with their documentation and records.

• Participate and support internal, external audits as needed.

• Performs other related duties as required: project management, presentation creation and strategic planning.

• May coordinates aspects of the complaint investigation team and associates who exercise responsibility for results in terms of investigation accuracy, completion time, and documentation. 

• Accountable for individual results and impact on the team.

• Shares experience with others to meet objectives in own area of responsibility.

• Identifies and implements efficiency and compliance improvements to the complaint investigation process.

• In concert with the department manager and escalation teams, strategize to direct the efforts to ensure Dispensing customer satisfaction.

• May provide regular and consistent updates to leadership on complaint investigation trends and observations.

• Develops and implements programs to establish and maintain quality standards of existing products and service, as well as developing programs to focus employees on quality improvements.

• Develops procedures & methods to investigate products, material, components and/or operational quality.

Qualifications (Education & Experience)

• BA, BS or comparable experience in Engineering or Technical discipline

• 5 years’ experience in Quality/Complaint Handling

• Strong knowledge of FDA regulations 21CFR820

• Strong knowledge of MDSAP standards

• Experience with SAP and TrackWise

• Strong Knowledge of Dispensing Solution Products

Knowledge, Skills & Abilities

• Has in-depth experience, knowledge, and skills in own job family. 

• Applies knowledge and skills to a wide range of standard and non-standard situations. 

• Works independently with minimal guidance 

• Acts as a resource for colleagues with less experience

• Meticulous attention to detail and accuracy.  

• Strong communication and organizational skills.

• Ability to solve problems and to meet multiple deadlines within a fast paced environment.

• Excellent writing skills, knowledgeable of good documentation practices and writing to different audiences.

• Ability to work on multiple projects with various disciplines, flexibility and innovation. 

• Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook.

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