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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

Job Opening: Formulating Chemist

Aug 23, 2016 - news

MedTest: A Great Place To Work

Position:

Formulating Chemist

Type:

Full Time

Location:

Canton, Michigan

Duties & Responsibilities

  • Responsible for understanding and performing all aspects of the formulation process for both liquid and powdered reagents

  • Maintain and operate all formulating equipment including scales, grinders and mixers

  • Deliver QA samples as well as work in close cooperation with QA department in product formulating

  • Assist in performing inventory

  • Assist in maintaining and disposal of product waste

  • Responsible for maintaining proper handling and storage of raw materials and formulated products

  • 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

  • High School diploma or equivalent, or previous job experience in a chemical formulation position

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

Job Opening: Production Worker

Aug 23, 2016 - news

MedTest: A Great Place To Work

Position:

Production Worker

Type:

Full Time

Location:

Canton, Michigan

Duties & Responsibilities

  • Responsible for performing various aspects of the production process

  • Responsible for understanding and performing all aspects of the finished kit production process

  • Responsible for understanding and performing all aspects of the process for filling powdered products

  • Responsible for understanding and performing all aspects of the process for filling liquid products

  • 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

  • High School diploma or equivalent or previous job experience in a production position

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

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