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Mindray and MedTest announce FDA 510(k) Clearance for the BC-5390 Hematology Analyzer

Sep 14, 2016 - press releases

(Mahwah, New Jersey & Canton, Michigan)  Mindray announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray BC-5390 Auto Hematology Analyzer.  The Mindray BC-5390 Analyzer meets the testing needs of mid-volume hematology laboratories while offering state-of-the-art features commonly found on large volume analyzers.

The BC-5390 Hematology Analyzer provides a complete blood count with 21 parameters and a 5-part differential from a venous or capillary blood sample.  The built in autoloader with 40 sample capacity enhances operator walk-away time. Hemoglobin analysis is performed using cyanide-free reagents. The analyzer processes up to 60 samples per hour and stores up to 100,000 results with histograms. The barcode reader and optional LIS connectivity enables seamless sample data transmission.  Nearly all scheduled maintenance procedures are automated by touch buttons.  The intuitive software enhances workflow efficiency and offers the operator a pleasant user experience.” 

Caroline Li, General Manager of Mindray IVD North America, stated:  “We are excited to launch the BC-5390 Hematology Analyzer into the United States laboratory market.  Mindray enjoys satisfied customer experiences with this analyzer outside of the US and looks forward to adding US customers to our installed base.  The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.  This commercialization further enhances Mindray’s presence in the US in-vitro diagnostic market enabling us to continue to introduce new and innovative products for the clinical laboratory in the future.”

MedTest is a primary distributor of the BC-5390 Hematology Analyzer in the US and Canada. Hanjoon Ryu, CEO of MedTest, stated: “Partnered with the bench-top BS-200 Chemistry Analyzer, the BS-480 Chemistry Analyzer or the BA-800M Chemistry Analyzer, the addition of the BC-5390 Hematology Analyzer enables MedTest to offer a total testing solution that meets the requirements of both the hematology and chemistry laboratories. We are delighted to share this announcement with our strategic partner, Mindray.”

About Mindray:  Mindray is a leading developer, manufacturer and marketer of medical devices worldwide. Mindray maintains the global headquarters in Shenzhen, China, the U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From the main manufacturing and engineering base in China, Mindray supplies through our worldwide distribution network a broad range of products across three primary business segments, namely patient monitoring and life support, in-vitro diagnostic, and medical imaging systems.

About MedTest:  MedTest is a diagnostics company that provides automated, fast, and cost effective blood and urine testing solutions for diabetes, cardiovascular disease, drugs of abuse, pain management and wellness testing.  In June 2013, MedTest acquired Pointe Scientific, a company that has been developing, manufacturing and distributing clinical diagnostic products including clinical chemistry reagents and instruments in the United States and internationally since 1981.  In the fall of 2014, MedTest acquired Clinitox Diagnostix, a company that manufactures and supports drug confirmatory testing via Liquid Chromatography/Mass Spectrometry (LC/MS).

For additional information:

MedTest Mindray
Debbie Whitehair, MT(ASCP)SC Caroline Li 
Vice President, Marketing General Manager of  Mindray IVD North America
484.748.1603 800.288.2121 Ext. 2152
dwhitehair@medtest.com c.li@mindray.com
www.medtest.com www.mindraynorthamerica.com

PR-M1115-01   09/16

Job Opening: Shipping Manager

Sep 8, 2016 - news

MedTest: A Great Place To Work

Position:

Shipping Manager

Type:

Full Time

Location:

Canton, Michigan

Duties & Responsibilities

  • Manage, supervise, and coordinate activities of warehouse personnel engaged in verifying and maintaining records for incoming and outgoing shipments

  • Manage all important documents, such as; advanced shipping notices, pick slips, bills of lading, etc.

  • Responsible for training and supervising all shipping/receiving personnel

  • Responsible for making recommendations to Senior Management on the selection, retention, and/or release of staff in the Shipping Department

  • Ensure that shipping regulations and export policies are followed

  • Coordinate the product shipment schedule with the product availability schedule, to ensure prompt delivery to all customers

  • Collaborate with warehouse, purchasing, and other company managers to optimize current processes

  • Control the Shipping Department budget

  • Coordinate imports, clearances, documentation, and deliveries

Candidate

  • Strong leadership and communication skills, with the ability to motivate shipping/receiving personnel

  • Experience in directing and evaluating subordinates

  • Knowledge of prevailing shipping requirements, and all import and export regulations

  • Solid grasp of international shipping requirements and non-EU customs laws

  • Has an energetic and creative approach to problem-solving with an ability to handle heavy pressure situations

  • Ability to work within an ambiguous, fast-moving environment, with a resourcefulness in setting priorities

  • Computer savvy with an extensive knowledge of Microsoft Office 

  • Solid knowledge of logistics procedures

  • College degree and/or a minimum of 5 years' proven experience as a Shipping Manager, and in Shipping Management

  • Advantages - BSc/BA in supply chain, logistics, or a relative field, Forklift Certification 

  • Qualities - Integrity, Credibility, Commitment, Flexibility, Multitasker

Please submit your resume or CV (Curriculum Vitae) and cover letter to marketing@medtest.com

Job Opening: QS/RA Manager

Sep 6, 2016 - news

MedTest: A Great Place To Work

Position:

QS/RA Manager

Type:

Full Time

Location:

Canton, Michigan

Duties & Responsibilities

  • Ensure compliance with all applicable regulations, standards, systems, procedures and practices.  Includes Quality System, cGMP, GLP, CLIA, ISO, EU and other regulatory standards

  • Act as a liaison between MedTest and all relevant medical device regulatory agencies (e.g. US Food and Drug Administration (FDA), Health Canada (HC), International Standards Organization (ISO), etc)

  • Act as the Quality System Management Representative

  • Provide strategic input on compliance issues

  • Ensure the promotion and awareness throughout the organization of all applicable regulatory and customer requirements

  • Review product changes for impact on regulatory filings worldwide

  • Research regulatory issues and provide guidance and advice to colleagues

  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change controls and Corrective and Preventive Actions to the adhered timelines 

  • Manage regulatory information and track and control submissions

Candidate

  • Strong leadership skills

  • Good verbal and written communication skills

  • A team player who can work well with peers and senior personnel and deliver pragmatic but sound quality solutions to identified issues

  • Ability to promote change assertively with tact and diplomacy

  • Ability to prioritize, plan, and evaluate deliverables to established strategic goals

  • Minimum Bachelor's of Science Degree, Clinical Laboratory, or equivalent

  • Minimum 5 years hands-on experience within an ISO quality system as related to the medical device industry

  • Ten or more years' experience in Quality System Management 

  • Experience in developing, implementing, and maintaining effective manual and electronic QMS Quality System Processes

  • Specific experience and/or training in auditing, quality training, procedure writing, supplier quality assurance, verification and validation, and creating management level presentations and reports

  • Advantages - Experience with root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma. Formal education in Quality (e.g., CQE / CQM)  

    Please submit your resume or CV (Curriculum Vitae) and cover letter to marketing@medtest.com

Job Opening: Technical Service Specialist

Sep 2, 2016 - news

MedTest: A Great Place To Work

Position:

Technical Service Specialist

Type:

Full Time

Location:

Canton, Michigan

Duties & Responsibilities

  • Troubleshoot, resolve, and verify the resolution of any MedTest assay, software, and/or hardware related issue

  • Proactive and reactive, timely and courteous, customer follow-up and support

  • Provide remote technical support via phone, internet, and/or email according to MedTest established protocols

  • Assist QA Laboratory and R&D departments when needed

  • Develop training material, participate in product training, and serve as a resource in instrument operation and maintenance

  • Participate in the Department's after-hours on-call phone support rotation

  • Perform scheduled maintenance on laboratory equipment in the Canton, MI facility

  • Promote the use of MedTest reagents and supplies, and encourage the renewal of service contract's when nearing expiration

Candidate

  • MLT/MT or equivalent, or experience in a diagnostic/laboratory setting

  • Strong communication and interpersonal skills

  • Ability to follow and understand written protocols

  • Positive and team oriented attitude

  • Desire to drive excellent customer support and retention

  • Multi-task oriented

Please submit your resume or CV (Curriculum Vitae) and cover letter to marketing@medtest.com

Job Opening: Shipping Clerk

Sep 1, 2016 - news

MedTest: A Great Place To Work

Position:

Shipping Clerk

Type:

Full Time

Location:

Canton, Michigan

Duties & Responsibilities

  • Responsible for checking the accuracy of incoming and outgoing shipments

  • Assemble wooden and cardboard containers or selects pre-assembled containers

  • Arrange shipments using different carriers

  • Pull, pack, and ship finished products

  • Able to complete UPS, Federal Express, US Postal, and key international shipping expeditor forms

  • Determine storage areas for incoming shipments and allocate appropriate space within the warehouse

  • Any other duties and responsibilities as needed

Candidate

  • Good reading and math skills

  • Must have the ability to follow and understand written protocols

  • Good communication skills

  • Flexible

  • Multi-task oriented

  • Must be able to lift up to 25 pounds

  • International export experience a plus

  • High School diploma or equivalent, or previous job experience with shipping procedures, routes, and rates

Please submit your resume or CV (Curriculum Vitae) and cover letter to marketing@medtest.com

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