What are the responsibilities and job description for the Design Assurance Engineer position at Medical Engineering Consultants (MEC)?
Job Design Assurance Engineer (Junior Level) - Contract located near Minneapolis, Minnesota
**Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients' needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME's (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients' expectations.**
Onsite
Job Purpose
- Develops, establishes and maintains quality engineering methodologies systems and practices which meet our client's customer and regulatory requirements.
- Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
- Provides focused quality engineering support within new product development or sustaining support.
Design Assurance Key Responsibilities
- Works cooperatively with R&D, Process Development, Quality, Production, Regulatory and Marketing to ensure project success.
- Provides support for design verification and validation to include any of the following: writing protocols and/or reports, test method validation, testing coordination and evaluation of test results.
- Acts as an effective team member in supporting quality disciplines, risk management, documentation decisions and practices.
- Apply sound systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Quality Systems Duties And Responsibilities
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
- 0 - 1 Year with BS
- Additional Engineering or Scientific degrees
- Test Validation knowledge experience
- Hands on experience
- internships
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.
- Sponsorship is not available for this position
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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.