Job description

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address Diresh.Krishnan@generistek.com can be reached on # (630) 576-9065 . We have Contract role Analyst, Product Surveillance f or client at Plymouth, MN. Please let me know if you or any of your friends would be interested in this position. Position Details: Analyst, Product Surveillance- Plymouth, MN Location : Plymouth, MN – 55442 (100% Onsite) Project Duration : 4-6 Months of contract Shift Timing : 8:00 AM to 4:30 PM (Mon to Fri) Pay Rate : $30.50 per hour on W2 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 MS 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. To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address Diresh.Krishnan@generistek.com can be reached on # (630) 576-9065 . About generis Tek : generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.

Requirements

Must-haves

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address Diresh.Krishnan@generistek.com can be reached on # (630) 576-9065 .
We have Contract role Analyst, Product Surveillance f or client at Plymouth, MN. Please let me know if you or any of your friends would be interested in this position.
Analyst, Product Surveillance- Plymouth, MN
Location : Plymouth, MN – 55442 (100% Onsite)
Project Duration : 4-6 Months of contract
Shift Timing : 8:00 AM to 4:30 PM (Mon to Fri)
Pay Rate : $30.50 per hour on W2
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.
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.

Nice-to-haves

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.

Application prep

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