Requirements:

• High School Diploma, but would prefer either Associate's degree/Bachelor's degree or 2+ years related experience (preferred) and/or training; or equivalent combination of education and experience.

• Must be able to lift approximately 50lbs.

• Proficient in Microsoft Office, Excel, PowerPoint, etc.

• XA/PowerLink knowledge and experience preferred.

• Excellent written and verbal skills.

• Must be detail oriented, thorough, and be able to multi-task as well as prioritize.

• Must be a team player.

• Hours 8am - 5pm - Monday thru Friday

• Ability to travel if necessary.

Essential Duties and Responsibilities:

• Product Change Requests (CRs) Obtain approvals Process the change(s) in PowerLinkScan completed CRs along with all supporting documentation to WebDocs.File CRs for the current year.Box previous years CRs to be kept in storage for the total retention period per QA-C-700-3.Send Vendor Notification forms to vendors along with new and/or revised drawings or purchase material specifications.

• Document Change Requests (DCRs) Prepare document changes in Microsoft Office/Word and/or Excel. Email to applicable personnel for initial review. Once initial review is complete; upload into Entropy for approval.Once the document is approved and “Published” via Entropy, move the copy from signatures to Docctl and move the obsolete copy to the Obsolete Documents folder on the network.Update the status report which lists current version number.

• Instructions for UseCreate and revise Instructions for Use.Obtain quotes for translation of Instructions for Use (we currently have IFUs in 16 different languages).File all current IFUs in Document Control.

• External Regulations and StandardsOrder regulations and standards via the internet.Download new/revised standards to the network for easy access for all employees.Scan hard copies of regulations/standards that cannot be downloaded from the supplier’s website. Update the log when new or revised standards are obtained.

• Quality RecordsProvide all departments with labels for the contents of their boxes to be kept in storage.At least yearly box work orders.At least yearly box CRs.Maintain the Record Storage Log on the network.Communicate with shipping personnel to retrieve archived documents from the warehouse, when necessary.Scan/upload work orders to web-docs.

Qualifications:

• Qualified applicants must be hands on, detail oriented, hold a Bachelor's Degree in an engineering discipline with 2 + years of related medical device experience preferred.

• There is no relocation assistance or Visa sponsorship available for this position.

• Please send salary requirements with resume.

Job Type: Full-time

Required experience:

• Medical device: 2 years

Required education:

• Bachelor's

Requirements:

• Seasoned professionals are required to possess at minimum a four-year degree in an engineering, scientific or technical discipline.

• Prior management or leadership experience is preferred.

• Attention to detail and organizational skills are a must.

• Ability to be a team-player and work cohesively with all levels of staff members and multiple internal and external departments.

• Working knowledge of all regulations required by regulatory agencies.

• Prefer 5-7 years' experience in the Medical Device industry.

• Six Sigma Green Belt is preferred.

• 5-7 years in an engineering environment, designing, specifying, assembly and validating.

• Excellent written and oral communication skills.

• Problem-solving ability.

• Travel at minimum 5%.

• Must be proficient with Solid Works.

• Must have experience with risk analysis tools, such as FMEA.

• Must have experience with project management.

• Relocation assistance and Visa sponsorship are not available for this position.




Job Type: Full-time

Required experience:

• Medical devices: 5 years

• Engineering: 5 years

Required education:

• Bachelor's

Requirements:

• Minimum of a Bachelor's degree in English, Engineering, Life Sciences, or Health Sciences.

• At least 5 years of experience in the Medical Device industry.

• Minimum of 3 years recent experience writing Clinical Evaluation Reports.

• Experience writing Clinical Trials Summary Reports a plus.

• Knowledge of research methodology, including clinical investigation design and biostatistics preferred.

• Must have a strong understanding of medical terms and be able to use diagrams, anatomical images, photographs or charts to explain medical content.

• Knowledge of clinical dialysis, fluid infusion, and fluid drainage procedures a plus.

• Working knowledge of ICH-GCP and EU Medical Device Directive/Medical Device Regulations.

• Writing samples may be requested during the interview process.

• This position has the potential to work remotely.

• Relocation assistance and Visa sponsorship are not available for this position.

Job Type: Full-time

Required experience:

• Writing Clinical Evaluation Reports: 3 years

• Medical Device industry: 5 years

Required education:

• Bachelor's

Required experience:

• Regulatory: 2 years

• Medical Devices: 2 years

• FDA: 1 year

Job Type: Full-time

Required education:

• Bachelor's

Required license or certification:

• RAC Certification

Qualifications:

• BS degree in Science, Engineering, Materials or Mathematics preferred from an accredited college or university.

• Advanced degree a plus.

• Six Sigma and Lean training and/or experience is a plus.

• ASQ Certification is a plus.

• MS Office Applications, Power Point, SharePoint, PowerLink, MAPICS, MS Project.

Certifications, Licenses, Registrations.

• Current Passport - for travel to Mexico facility as required.

• Prefer Lean Manufacturing and Six Sigma Green Belt.

Essential Duties and Responsibilities:

• Complaint investigation, validation support, development of inspection plans, failure analysis, testing, gauging, vendor management issues, and statistical process control.

• Work with management on quality planning (both long and short term) supporting diagnosis of quality problems ( both internal and external), corrective and preventative action programs and continuous improvement programs.

• New Product and Development Process, Design Reviews and all aspects of Design Control, including, but limited to Quality Planning, FMEA, Control Pans, Hazard Analysis, Biocompatibility, sterilization, and packaging/shelf life studies activities.

• Define deliverable quality requirements as input to project plans Material Review Board (MRB) process (Purchased materials and in-house manufactured product).

• Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems and to improve vendor quality.

• Prepare Vendor QA/Inspection protocols.

• Utilize standard statistical analysis techniques to determine product specifications. Participate in vendor site audits and work with suppliers to improve quality of both delivered parts and internal quality processes.

• Develop, validate, document and refine QA Test and Inspection procedures.

• Select and acquire equipment /tooling as required.

• Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.

• Develop Process Validation Master Plans and IQ, OQ, PQ, PPQ Protocols.

• Define sampling plans with statistical rationales, process control plans, and apply SPC to mfg applications.

• Monitor and lead improvements based on the evaluation of results.

• Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA engineering areas of expertise and lean tools.

• Provides direction in the completion of projects by displaying excellent interpersonal skills and completing projects according to specified time lines.

• Support Company Strategies as required.

• Travel as required to perform the objectives and end results of this function.

• Perform other related duties as may be reasonably assigned in the course of business.

Required experience:

• Shipping and Receiving: 2 years

Required education:

• High school or equivalent

Required license or certification:

• Valid Driver's License

Qualifications:

• Bachelor's Degree in Supply Chain Management, Statistics or related discipline, 5+ years related experience and/or training; or equivalent combination of education and experience.

• Proficient in research, data analysis, statistics and mathematics.

• Inventory, Forecasting, and Planning experience is preferred.

• Strong knowledge of ISO 13485 is preferred.

• Detail oriented.

• Problem-solving aptitude.

• Excellent communication skills.

• Outstanding organizational ability.

• Must be a team-player and able to work on cross-functional teams.




Please submit salary requirements with resume.

No phone call inquiries will be accepted.

No Sponsorship is available for this position.