Biolinq
Overview
Director Technical and Customer Support at Biolinq. Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions, including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. Job Purpose
This is a key Quality Director role responsible for establishing, leading, and managing the Complaint department, ensuring compliance with global regulatory requirements. This highly visible role will focus on establishing the Customer Service, Technical Support and Complaint processes and be responsible for reviewing Customer Complaints and identifying reportable events. They will work with cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality to oversee the investigate and review of complaints. This role requires significant attention to detail, excellent verbal and written communication skills, and the ability and critical thinking skills to prioritize competing projects. Duties and Responsibilities
Develop and implement strategies for handling product complaints, including investigation, reporting, and corrective actions Create a “Best in Class” customer service model and strategy based on customer needs and continuously improve the customer care operating model Evaluate complaints for reportable events in the US and international agencies Utilize an electronic complaint handling and event reporting system. Manage electronic Medical Device Reports for US reportable events Oversee the monitoring and trending of complaint data to identify potential product issues and implement preventive measures Create a culture of continuous improvement, consistently focused on providing service that adds value to the customer experience Demonstrated experience in leading technical support and complaint teams in high growth start-ups or established high volume medical device corporations Develop and oversee the call center and the customer service, technical support and complaint teams Develop reporting and data analysis strategies to provide the appropriate insight into product usage and process improvement Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development to ensure alignment on technical support and vigilance activities Maintain up-to-date knowledge of industry standards and regulatory requirements for medical device complaints/vigilance Prepare and present reports to senior management on activities and key performance metrics Qualifications
Bachelor’s degree required, advanced degree preferred in Biological, Chemistry, Quality, Engineering or related discipline Minimum of 10 years of experience in medical device or biotech industry Minimum of 8 years of experience in Technical Support and Complaint Vigilance in a medical device or biotech setting; FDA and ISO regulated industry, MDSAP and/or MDR experience a plus In-depth knowledge of global regulatory requirements for medical device complaint vigilance, including FDA and EU MDR regulations Experience with electronic quality management systems as well as paper-based systems Proven leadership experience with a track record of managing teams and solving complex problems Strong analytical skills and the ability to interpret complex data Excellent communication and interpersonal skills to effectively present information and respond to questions from stakeholders Working Conditions
General Office and Laboratory Physical Requirements
Regularly required to stand, walk, sit, use hands to finger, handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear. Occasionally lift/move up to 15 pounds. Benefits
Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO. EEO and Other Notices
Biolinq is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The company complies with applicable laws and provides reasonable accommodation upon request during the application process to enable individuals with disabilities to perform essential functions. The company maintains a smoke-free workplace. Salary information: The U.S. base salary range for this role is $150,000 to $180,000, with actual compensation based on factors including skill set, depth of experience, education, certifications, and work location. The total compensation package may include an annual bonus or other incentive plans. This description is not an all-inclusive list of duties and responsibilities and the company may change duties at any time. Management may reassign duties as needed. This content is subject to change. The recruiter can share more about the total compensation during the hiring process.
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Director Technical and Customer Support at Biolinq. Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions, including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. Job Purpose
This is a key Quality Director role responsible for establishing, leading, and managing the Complaint department, ensuring compliance with global regulatory requirements. This highly visible role will focus on establishing the Customer Service, Technical Support and Complaint processes and be responsible for reviewing Customer Complaints and identifying reportable events. They will work with cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality to oversee the investigate and review of complaints. This role requires significant attention to detail, excellent verbal and written communication skills, and the ability and critical thinking skills to prioritize competing projects. Duties and Responsibilities
Develop and implement strategies for handling product complaints, including investigation, reporting, and corrective actions Create a “Best in Class” customer service model and strategy based on customer needs and continuously improve the customer care operating model Evaluate complaints for reportable events in the US and international agencies Utilize an electronic complaint handling and event reporting system. Manage electronic Medical Device Reports for US reportable events Oversee the monitoring and trending of complaint data to identify potential product issues and implement preventive measures Create a culture of continuous improvement, consistently focused on providing service that adds value to the customer experience Demonstrated experience in leading technical support and complaint teams in high growth start-ups or established high volume medical device corporations Develop and oversee the call center and the customer service, technical support and complaint teams Develop reporting and data analysis strategies to provide the appropriate insight into product usage and process improvement Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development to ensure alignment on technical support and vigilance activities Maintain up-to-date knowledge of industry standards and regulatory requirements for medical device complaints/vigilance Prepare and present reports to senior management on activities and key performance metrics Qualifications
Bachelor’s degree required, advanced degree preferred in Biological, Chemistry, Quality, Engineering or related discipline Minimum of 10 years of experience in medical device or biotech industry Minimum of 8 years of experience in Technical Support and Complaint Vigilance in a medical device or biotech setting; FDA and ISO regulated industry, MDSAP and/or MDR experience a plus In-depth knowledge of global regulatory requirements for medical device complaint vigilance, including FDA and EU MDR regulations Experience with electronic quality management systems as well as paper-based systems Proven leadership experience with a track record of managing teams and solving complex problems Strong analytical skills and the ability to interpret complex data Excellent communication and interpersonal skills to effectively present information and respond to questions from stakeholders Working Conditions
General Office and Laboratory Physical Requirements
Regularly required to stand, walk, sit, use hands to finger, handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear. Occasionally lift/move up to 15 pounds. Benefits
Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO. EEO and Other Notices
Biolinq is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The company complies with applicable laws and provides reasonable accommodation upon request during the application process to enable individuals with disabilities to perform essential functions. The company maintains a smoke-free workplace. Salary information: The U.S. base salary range for this role is $150,000 to $180,000, with actual compensation based on factors including skill set, depth of experience, education, certifications, and work location. The total compensation package may include an annual bonus or other incentive plans. This description is not an all-inclusive list of duties and responsibilities and the company may change duties at any time. Management may reassign duties as needed. This content is subject to change. The recruiter can share more about the total compensation during the hiring process.
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