Company Description

Since 2009, Info Way Solutions has earned a reputation as a full-service staffing firm that excels in a fast-paced marketplace. We have placed highly skilled professionals on a temporary, temporary-to-hire and direct-hire basis in the fields of accounting and finance, IT technology,office administration, marketing and design.
Info Way Solutions is dedicated to providing you quality professionals with well-matched skills to your unique hiring requirements and workplace environment. We collaborate with customers to consistently and cost-effectively plan, execute and deliver high-quality services and results.Our consultants are seasoned professionals who build long-term,trusted relationships that bring about a high level of energy, integrity, experience and value to our client’s work.
Our superior client-consultant relationships and in-depth insight of services have resulted in significant repeated business with clients. In addition, we are partners with best-in-class technology vendors that enable us to best determine the most appropriate hardware, software and services to cater to any of our client’s business needs. We have often collaborated with them to make optimal use of today’s technology while also planning for the future.
More than 50 customers – including mid-market leaders and many of the Fortune 500 Companies – rely on our expertise to leverage their investments.

Job Description

Responsible for cleaning\decontamination of returned product samples. After processing of samples, responsible for shipping samples to appropriate manufacturing location. Must be able to handle lifting of boxes on a daily basis. Will be responsible for lifting Biohazards shipping boxes with assistance from a second person to be 

placed on a designated cart; these boxes can weigh upwards of 55 pounds. 

Analyze samples using specific procedures and instrumentation. Maintain documentation. May provide assistance in troubleshooting results outside of predefined specifications. 

SUMMARY OF POSITION: 

The candidate will support the Post Market Vigilance Investigations team’s activities for the Patient Monitoring and Recovery (PMR) Division. These activities include; assist in managing the receipt of incoming physical complaint product, conducting follow ups with accounts and/or International Subsidiaries to rectify discrepancies with product receipt, assisting in managing the process flow of complaint investigations, performing Device History Record Reviews, and performing root cause analysis on PMR Product customer returns to ensure high levels of quality, reliability, safety, and efficacy. Additional responsibilities include management of clinically applied medical device retains and associated paper records in accordance with Covidien Medtronic Record Retention Policies and support staffing needs. 

ESSENTIAL FUNCTIONS: 

• Assist PMV Investigations Coordinator with managing receipt of physical complaint product samples, in addition to corresponding with domestic and international accounts to rectify discrepancies in product receipt. 

• Assist in the coordination of sanitization of clinically applied medical device returns and shipment to respective Medtronic Manufacturing facilities, as well as coordinating the investigation process with internal Engineering and Quality groups. 

• Test and thoroughly evaluate clinically applied surgical medical devices of various degrees of complexity to determine root cause analysis within a closely monitored time frame. 

• Identifying the appropriate test method/regiment from existing Standard Operating Procedures for complaint sample evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination. Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards. 

• Replicate reported failure mode with bench top or in vivo test methods and document observations accordingly. 

• Initiate and distribute Corrective Action Requests to Manufacturing or Engineering Departments as needed. 

• Prepare technical investigation reports based on results of evaluation and/or review of the manufacturing plant reports to be documented in the QA (Quality Assurance) Department complaint database and incorporated into customer response letters. 

• Certification with OSHA’s BloodBorne Pathogens Standard 29 CFR 1910.1030 and adherence to Corporate and Local Environmental Health and Safety Policies. 

MINIMUM REQUIREMENTS: 

Minimum Experience: 2 to 3 yrs

• Academic or work experience in a laboratory or manufacturing environment. Experience with laboratory equipment or test equipment or manufacturing equipment highly desirable. 

• Experience with medical devices preferred but not required. 

Skills/Qualifications: 

• Must be proficient with MS Office (with emphasis on Excel and Word). 

• Critical independent thinking and timely follow up. 

• Time management skills. 

• Excellent written and verbal skills necessary. 

QD003425-001, Rev A 

ORGANIZATIONAL RELATIONSHIPS/SCOPE: 

• Quality Assurance 

• Manufacturing 

• Engineering 

• Research and Development 

• Regulatory Affairs 

• Legal 

• Marketing/Sales 

WORKING CONDITIONS: 

Biohazardous laboratory environment requiring use of personal protective equipment in accordance with CDC and OSHA regulations. 

Responsible for cleaning\decontamination of returned product samples. After processing of samples, responsible for shipping samples to appropriate manufacturing location. Must be able to handle lifting of boxes on a daily basis, some boxes weigh upwards of 50 pounds each. 

Must be able to handle lifting of boxes on a daily basis. Will be responsible for lifting Biohazards shipping boxes with assistance from a second person to be 

placed on a designated cart; these boxes can weigh upwards of 55 pounds. 

Analyze samples using specific procedures and instrumentation. Maintain documentation. May provide assistance in troubleshooting results outside of predefined specifications.

Qualifications

Education: BS Degree in a Science or Engineering discipline.