Analyst, Product Surveillance

Summary

Analyst, Product Surveillance

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances. At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Job Description

Position Summary The Product Surveillance Analyst supports post-market surveillance activities through the inspection, testing, and evaluation of returned medical devices. This position assists in product complaint investigations by performing laboratory analyses, documenting findings, and supporting the determination of device performance characteristics. The role requires strong attention to detail, adherence to procedures, and accurate documentation within quality system requirements. Key Responsibilities Perform receipt, inspection, and evaluation of returned medical devices associated with customer complaints. Execute laboratory testing and product performance evaluations according to approved work instructions and procedures. Document observations, test results, and investigation findings in complaint handling systems and laboratory records. Support root cause investigations by gathering and analyzing product performance data. Operate laboratory equipment, tools, and test fixtures safely and effectively. Review device history information, investigation records, and product specifications as needed to support evaluations. Maintain compliance with FDA regulations, quality system requirements, and internal procedures. Collaborate with engineers, analysts, and quality personnel to support complaint investigations and post-market surveillance activities. Ensure timely completion of assigned investigations while meeting quality and productivity expectations. Participate in continuous improvement initiatives and support laboratory organization and maintenance activities. Required Qualifications A minimum of 1 year experience in working in a lab environment with hands on analysis/testing (preferably in med-device industry but open to any others). Bachelor's degree in a science, engineering, healthcare, or technical field; or equivalent combination of education and relevant experience. Strong attention to detail and organizational skills. Ability to follow detailed procedures and accurately document results. Basic computer skills, including experience with Microsoft Office applications. Effective written and verbal communication skills. Preferred Qualifications Experience in the medical device, pharmaceutical, biotechnology, or regulated manufacturing industry. Experience performing laboratory testing, product analysis, troubleshooting, or complaint investigations. Familiarity with FDA Quality System Regulations (21 CFR Part 820), complaint handling, and post-market surveillance processes. Experience working with electronic quality management systems such as EPIQ or similar complaint handling databases. Physical Requirements Ability to work in a laboratory environment. Ability to handle and inspect small medical device components. Ability to sit, stand, and use laboratory equipment for extended periods. Schedule: 8 am - 4 pm (Monday - Friday)

Location: Plymouth, MN

Kyyba is an Equal Opportunity Employer. Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need. It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665

Rewards: Medical, dental, vision 401k Term life Voluntary life and disability insurance Optional Pre-paid legal plan Optional Identity theft plan Optional Medical and dependent FSA Work-visa sponsorship Opportunity for advancement Long-term assignment with opportunity for hire by client

SELECT AWARDS An INC 5000 company for 10 years Corp! Michigan Economic Bright Spots Crain's Detroit Business Top Staffing Service Companies in Detroit TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions Best of MichBusiness winner in HR Wizards & Partnerships Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest 101 Best & Brightest Companies to Work for in Michigan

Job Description

Analyst, Product Surveillance

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances. At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Job Description

Position Summary The Product Surveillance Analyst supports post-market surveillance activities through the inspection, testing, and evaluation of returned medical devices. This position assists in product complaint investigations by performing laboratory analyses, documenting findings, and supporting the determination of device performance characteristics. The role requires strong attention to detail, adherence to procedures, and accurate documentation within quality system requirements. Key Responsibilities Perform receipt, inspection, and evaluation of returned medical devices associated with customer complaints. Execute laboratory testing and product performance evaluations according to approved work instructions and procedures. Document observations, test results, and investigation findings in complaint handling systems and laboratory records. Support root cause investigations by gathering and analyzing product performance data. Operate laboratory equipment, tools, and test fixtures safely and effectively. Review device history information, investigation records, and product specifications as needed to support evaluations. Maintain compliance with FDA regulations, quality system requirements, and internal procedures. Collaborate with engineers, analysts, and quality personnel to support complaint investigations and post-market surveillance activities. Ensure timely completion of assigned investigations while meeting quality and productivity expectations. Participate in continuous improvement initiatives and support laboratory organization and maintenance activities. Required Qualifications A minimum of 1 year experience in working in a lab environment with hands on analysis/testing (preferably in med-device industry but open to any others). Bachelor's degree in a science, engineering, healthcare, or technical field; or equivalent combination of education and relevant experience. Strong attention to detail and organizational skills. Ability to follow detailed procedures and accurately document results. Basic computer skills, including experience with Microsoft Office applications. Effective written and verbal communication skills. Preferred Qualifications Experience in the medical device, pharmaceutical, biotechnology, or regulated manufacturing industry. Experience performing laboratory testing, product analysis, troubleshooting, or complaint investigations. Familiarity with FDA Quality System Regulations (21 CFR Part 820), complaint handling, and post-market surveillance processes. Experience working with electronic quality management systems such as EPIQ or similar complaint handling databases. Physical Requirements Ability to work in a laboratory environment. Ability to handle and inspect small medical device components. Ability to sit, stand, and use laboratory equipment for extended periods. Schedule: 8 am - 4 pm (Monday - Friday)

Location: Plymouth, MN

Kyyba is an Equal Opportunity Employer. Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need. It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665

Rewards: Medical, dental, vision 401k Term life Voluntary life and disability insurance Optional Pre-paid legal plan Optional Identity theft plan Optional Medical and dependent FSA Work-visa sponsorship Opportunity for advancement Long-term assignment with opportunity for hire by client

SELECT AWARDS An INC 5000 company for 10 years Corp! Michigan Economic Bright Spots Crain's Detroit Business Top Staffing Service Companies in Detroit TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions Best of MichBusiness winner in HR Wizards & Partnerships Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest 101 Best & Brightest Companies to Work for in Michigan