Job Description:

Complaint Investigator - Home Based

BioTelemetry, a Philips Company, is the leading remote medical technology company focused on delivery of health information to improve quality of life and reduce cost of care. We provide remote cardiac monitoring, centralized core laboratory services for clinical trials, remote blood glucose monitoring and original equipment manufacturing that serves both healthcare and clinical research customers. BioTelemetry monitors over four billion heartbeats per day, processes over one million patients each year, supports some of the largest clinical trials and is pioneering patient care monitoring by connecting people with their care teams. It is the pioneer in remote patient monitoring, revolutionizing healthcare with its suite of cardiac monitoring devices, including its FDA-cleared ePatch and Mobile Cardiac Outpatient Telemetry (MCOT) monitors. BioTelemetry advances health by providing technology and services that enable healthcare providers to monitor and diagnose patients and clinical research subjects in a more efficient, accurate and cost-effective manner. We are passionate about connecting people with solutions that save lives, and our growth reflects our focus, commitment and passion for the important work we do each day. As one of the fastest growing connected health companies in the market, we are looking for people to join our team who share our passion and focus.

Overall Job Summary

The Complaint Investigator will be responsible for evaluating and resolving complaints, initiating CAPAs, analyzing complaint data and other additional data as needed. Provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations.

Essential Duties/Responsibilities:

• Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally.


• Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.


• Initiate complaint in process and applicable tool.


• Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint


• Communicate with customers, call center reps and FSEs to gather more data on complaints as needed.


• Assess if the Risk assessment is covering the hazard in the complaint.


• Complete all needed records in a timely and accurate manner.


• Confirm complaint condition and determine corrective action (including CAPA as needed).


• Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed.


• Responsible to evaluate, investigate, and resolve complaints. Completes initial assessment of reportability and escalates to manager to determine action, when necessary. Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints.


• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Has a complete knowledge of company products and services. Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.


• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.

Other Duties/Responsibilities:

• Other duties/responsibilities, as required/relevant.

Education and Experience Requirements:

Education:

• Bachelor's degree.

Relevant Work Experience:

• 3+ years of related experience in a medical device or regulated industry.


• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98- 282), Japanese MHLW Ordinance 169, and ISO 9001.


• Markets: Local post market surveillance regulation (21CFR, MDD93/42/EEC, other applicable market regulations), ISO14971 Risk Management.


• Previous experience in Medical device and or applicable Consumer product. Product Knowledge is preferred.

Required Knowledge, Skills, and Abilities:

Knowledge/Abilities -Technical Skills:

• Exposure to blue prints.


• Strong background in CAPA, non-conformances, audits, and change control. Strong knowledge and understanding of US Quality System Regulations 21 CFR Part 820, ISO 14971 and ISO 13485 regulations.


• Basic knowledge of customer complaint handling. Knowledge of risk management methodologies, data analysis and statistical techniques preferred.

Communication Skills (Verbal/Written):

• Strong verbal, written, and interpersonal skills.

Management/Leadership Skills:

• Ability to work with minimum supervision.

Customer Service:

• WECARE - BioTelemetry based customer centric program


• Ability to achieve deliverables within a project per the timeline.

Working Conditions/Physical Job Requirements:

Office environment/no specific or unusual physical demands/requirements/exposures

Specific physical requirements and/or exposures - Review list and provide details

(check all that apply and explain further in "Additional Information" space below):

Sitting Standing Seeing Hearing Speaking Writing Driving Lifting Carrying Pushing

Pulling Walking Climbing Reaching Bending Stooping Kneeling Other

Additional Information: May be required to carry up to 30 lbs. (e.g., customer returns).

EEO/AAP - Biotelemetry provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

NOTE: This job description is not intended to cover or contain a complete listing of all duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

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