Jonathan Mcelwee Email & Phone Number

Mason, Ohio, Us

Mason, Ohio, Us

Mason, Ohio, Us

Mason, Ohio, Us

Mason, Ohio, Us

Miamisburg, Oh, Us

Prepare and file Traditional and Special 510(k)s to obtain regulatory clearance to sell various spinal implants in the United States.Construct and submit European Technical Files according to the Medical Device Directive.Continually communicate with Engineering, Sales, and Marketing to maintain awareness of new product development.Assist Engineering in maintaining and updating the Design History Files for different medical devices.Process customer feedback and collaborate with cross-functional teams to drive product improvement.Compile clinical literature and create Clinical Evaluation Reports.Establish various regulatory and quality compliance Standard Operating Procedures and Work Instructions and continually ensure maintenance thereof. Updated the Company's complaint handling system to assure full compliance with FDA 21 CFR Part 820 and ISO 13485:2003.

Miamisburg, Oh, Us

Performed complaint handling, investigation, and reporting duties in compliance with internal quality systems and regulatory standards.Implemented track and trend analysis of complaints.Performed inspections of incoming and returned-from-field products utilizing vision systems, comparators, calipers, and micrometers.Established a newly developed inspection procedure for manufactured medical device products arriving at the Facility.Created and maintained CAPAs for customer complaints and supplier non-conformances.

Fridley, Minnesota, Us

Maintained a working knowledge of multiple medical device product lines as well as an understanding of the surgical procedures (Bariatric, Gastrointestinal, and Gynecological) that these devices are utilized in.Prepared timely submissions of all Medical Device Report's and European Vigilance reports.Applied Microsoft Excel and Access knowledge of analysis to track and trend product complaints worldwide.Communicated and coordinated cross-functional teams from R&D, Engineering, and Sales & Marketing to drive product improvement and respond to market needs.Presented customer feedback and complaint trending information monthly to approximately 50 members of upper-management, R&D, Engineering, and Sales & Marketing.

Fridley, Minnesota, Us

Maintained a working knowledge of multiple product lines including the GIA* surgical stapler, the EndoStitch* endoscopic suturing device, and surgical sutures, including Surgipro* II, Polysorb, and Biosyn.Independently processed approximately sixty medical supply complaints per week.Complied with the timeline of 7 days for complaint processing and investigation. Performed a multitude of quality performance tests to determine the cause of the reported conditionCreated a report summary of each investigation performed.

Blackfriars, London, Gb

Independently led a research project for formulation liquids and presented methodology, testing, and results to the Unilever R&D team.Supported a newly developed and highly revolutionary cost-reduced formulation for superior mildness and moisturization potential in body care through batch formulation.Evaluated more efficient techniques to mix formulation ingredients and shared outcomes with key formulation developers.Assessed physical stability of products by determining how different environmental variables influence product effectiveness and shelf life endurance.Trained on and independently operated laboratory equipment including mixers, homogenizers, viscometers, and pH meters.Collaborated with formulation chemists in a team environment while working in the laboratory.Maintained an organized, clean, and safe laboratory environment and efficient note-keeping records according to Good Laboratory Practices.