4 Jobs in Waukesha, WI
TekWissen ® is Hiring a Quality Specialist (Medical) Near Waukesha, WI
Position: Quality Specialist (Medical)Location: Waukesha, WI, 53186 Duration: 18 Months Job Type: Contract Work Type: Onsite Job DescriptionGENERAL PURPOSE OF JOB
- Responsible for ensuring compliance with applicable domestic and international standards and regulations through process review, approval, audits, and systematic maintenance of quality systems.
- Conducts compliance audits of complex documentation and data.
- Serves as QA interface to other departments and/or partners. Manage, mentor, and train staff in our quality system procedures, and the general regulatory compliance requirements associated with in-vitro diagnostic medical devices.
- Review quality outputs for compliance to internal and external requirements (21 CFR 820, ISO 13485, ISO 14971, MDSAP etc).
- Assist in chairing meetings as appropriate, including preparing appropriate agendas and meeting minutes with limited supervision. Monitors progress of such meeting agendas and reports progress as appropriate.
- Develops, maintains, and reports department metrics as needed.
- Serves as QA interface for design projects, ensuring compliance with applicable domestic and international standards and meeting project timelines.
- Review and assess appropriateness of document changes in accordance with internal procedures.
- Contributor to CAPA and NCR System. This includes reviewing adequacy of root cause, corrections, corrective actions, preventive actions, and effectiveness. In addition to reviewing CAPA records, owning CAPA records where appropriate.
- Develop, implement, and maintain quality system processes from a site level perspective.
- Review and assess change control, validation and qualification documents.
- Assist and own applicable portions of supplier management system, complaint system and design control.
- Assist in external and regulatory body audits.
- Functions as Change Control QA team lead ensuring compliance to all internal and external post development change activities and procedural and production improvements. QA liasion for Validaton/Verification activities. Responsible for determining if Regulatory Reporting is required (MDRs) as part of complaint management.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.
Job Summary
Full Time
Business Services
$86k-104k (estimate)
05/31/2024
07/08/2024
tekwissen.com
ANN ARBOR, MI
200 - 500
1998
Private
STEVE MOMORELLA
$10M - $50M
Business Services
Related Companies
About TekWissen ®
TekWissen provides enterprise software, web development, data warehousing, systems integration, information technology security services.
The job skills required for Quality Specialist (Medical) include ISO, Change Control, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Specialist (Medical). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Specialist (Medical). Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Specialist (Medical) positions, which can be used as a reference in future career path planning. As a Quality Specialist (Medical), it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Specialist (Medical). You can explore the career advancement for a Quality Specialist (Medical) below and select your interested title to get hiring information.
If you are interested in becoming a Quality Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Specialist job description and responsibilities
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Specialist jobs
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These quality checks ensure the ongoing reliability of the manufacturing process.
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Step 3: View the best colleges and universities for Quality Specialist.
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