Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Analyst, Product Surveillance

Expired Job

Voca Plymouth , MN 55442

Posted 3 months ago

Voca Professional has immediate openings available for Analyst, Product Surveillance professionals in Plymouth, Minnesota!

Voca connects healthcare professionals with fantastic health systems nationwide. Our goal is full partnership with our employees, providing the tools, guidance, and opportunities to help reach their individual goals. Voca provides benefits including insurance, 401k, and dedicated support!
Assignment details are provided below, were very excited to hear from you!

Assignment Details
Job Description
Duties: We are seeking an experienced, high caliber Analyst II, Postmarket Surveillance. The Postmarket Surveillance Analyst performs evaluations on various types of returned devices associated with reported complaints. Analysis involves using procedures, judgement and experience to determine appropriate testing of returned products; determining a well-documented and accurate root cause evaluation; reviewing of Device History Records; coordinating product testing/analysis with other departments and external consultants; and preparing technical reports of evaluations. Other tasks include operating and maintaining the Postmarket Surveillance laboratory equipment, interpreting technical product specifications, maintaining clean and orderly work area, adhering to safety and biohazard procedures, being diligent of any unusual trends in product evaluations. Candidate should be willing to work independently with minimal guidance as well as participate in cross-functional complaint review groups on a regular basis or as requested and collaborate with other employees, customers, contractors, and vendors. In addition, candidate will support the Quality Management System (QMS), Environmental Management System (EMS), and comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Qualifications
Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work. Knowledge of global regulations for medical device reporting and medical terminology is a plus

  • Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously

  • Good problem-solving and proficient computer skills are required- Ability to work in a geographically diverse business environment

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization- Multitasks, prioritizes and meets deadlines in timely manner- Strong organizational and follow-up skills, as well as attention to detail

  • Ability to maintain regular and predictable attendance
    Shift
    8-4:30
    Traveler Benefits
    Partnering with Voca comes with a number of benefits including:
    Dedicated Recruiter
    Insurance
    401k
    Competitive, Flexible Pay Packages

Voca: The Spirit of Work

IND-DL


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Analyst II Product Surveillance

Abbott Laboratories

Posted 2 days ago

VIEW JOBS 11/11/2018 12:00:00 AM 2019-02-09T00:00 At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. JOB DESCRIPTION: Postmarket Surveillance Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering). The other role of the Postmarket Surveillance Analyst is performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; coordinating product testing/analysis with other SJM departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the Postmarket Surveillance Laboratory equipment. Job Duties:. Duties associated with complaint investigation: * Initiates and manages the complaint file * Maintains accurate entry of complaints in the database * Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices) * Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints * Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management * Prepares customer letters with investigation findings * Is diligent of any unusual trends in product complaints and communicates them to management * Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings) * Archives complaint records and retrieves information on closed investigations * Ensures accurate department procedures and work instructions are maintained * Train new employees to the complaint handling process * Provide support to the Legal Department regarding product complaints * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. * Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments * Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors * Performs other related duties and responsibilities, on occasion, as assigned * Postmarket Surveillance Analyst (product evaluations):Performs product evaluations in a timely manner * Executes product evaluations to develop a well-documented and accurate root cause evaluation * Coordinates product evaluations with other SJM departments and external consultants * Use procedures, judgement and experience to determine appropriate testing of returned products with minimal guidance * Reviews all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations) * Interprets/reviews technical product specifications, measurements and the Device History Record * Prepares technical reports of findings and enters them into the complaint system * Reviews external vendor/consultant evaluations and enters them into the complaint system * Maintains work area in clean and orderly condition and adheres to safety and biohazard procedures * Is diligent of any unusual trends in product evaluations and informs management * Independently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings * Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings) * Adheres to the device retention and disposal procedures * Ensures accurate department procedures and work instructions are maintained * Collaborate independently with other team members and departments needing product evaluation information * Be able to ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues) * Train new employees to the product evaluation process * Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements * Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments * Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors * Performs other related duties and responsibilities, on occasion, as assigned Qualifications: * Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work * Knowledge of global regulations for medical device reporting and medical terminology is a plus * Strong written and oral communication skills are required * Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously * Good problem-solving and proficient computer skills are required * Experience working in a broader enterprise/cross-division business unit model preferred. * Ability to work in a highly matrixed and geographically diverse business environment. * Ability to work within a team and as an individual contributor in a fast-paced, changing environment. * Ability to leverage and/or engage others to accomplish projects. * Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. * Multitasks, prioritizes and meets deadlines in timely manner. * Strong organizational and follow-up skills, as well as attention to detail. * Ability to travel approximately 10%, including internationally. * Ability to maintain regular and predictable attendance. JOB FAMILY:Operations Quality DIVISION:CAHF Cardiac Arrhythmias & Heart Failure LOCATION:United States > Minnesota : 5050 Nathan Lane N. ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Not specified MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott Laboratories Plymouth MN

Analyst, Product Surveillance

Expired Job

Voca