A Biomedical Engineer designs solutions to problems in medicine and biology to improve patient care. Combines engineering with medical and biological knowledge. May develop medical products designed to replace biological functions, such as prosthetic limbs or artificial hearts, or design equipment such as X-rays and surgical tools.
The Senior Quality Specialist, Product Surveillance is responsible for conducting quality-related activities that support the delivery of compliant, high-quality products, processes, services, and documentation. This role focuses on complaint handling, product surveillance, regulatory compliance, quality investigations, and continuous improvement initiatives. The position collaborates closely with cross-functional teams to ensure adherence to applicable quality and regulatory requirements.
Key Responsibilities:
Conduct product surveillance and quality assurance activities in accordance with established quality systems and regulatory requirements. Review, assess, and document product complaints while ensuring accurate and timely completion of records. Prepare and maintain high-quality technical and medical documentation related to quality events and investigations. Analyze quality and surveillance data to identify trends, risks, and opportunities for continuous improvement. Utilize reporting and analytical tools to support quality monitoring and business decision-making. Collaborate with cross-functional teams including quality, regulatory, operations, and engineering functions. Support compliance initiatives and ensure alignment with applicable global regulatory requirements. Investigate quality issues and develop practical, compliant solutions to complex problems. Participate in quality improvement projects and contribute subject matter expertise to project teams. Provide guidance and oversight on assigned quality activities while supporting organizational objectives. Represent the quality function on cross-functional initiatives as needed. Perform additional quality-related duties as assigned.
Required Qualifications:
Bachelor's degree in Life Sciences, Engineering, or a related discipline, or an equivalent combination of education and experience. Minimum of 4 years of experience in quality assurance, product surveillance, complaint handling, or a related quality function. Experience with complaint handling and quality documentation. Strong medical writing and technical documentation skills. Knowledge of regulatory requirements and quality system compliance. Experience analyzing quality data and identifying trends. Proficiency with MS Excel and Power BI. Strong cross-functional communication and collaboration skills. Ability to manage multiple priorities with minimal supervision. Experience supporting continuous improvement initiatives.
Preferred Qualifications:
Experience within the healthcare, medical device, pharmaceutical, or life sciences industry. Background in product surveillance or post-market quality activities. Knowledge of global regulatory expectations and quality standards. Experience leading quality-related projects or initiatives. Experience mentoring junior quality professionals or contractors.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.
Pay Range:
$30/hr to $38/hr If interested, you can also share your resume at gagandeep.singh@collabera.com
