Medical Engineering Consultants
Software Quality Engineer
Medical Engineering Consultants, Osseo, Minnesota, United States, 55311
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Software Quality Engineer
role at
Medical Engineering Consultants (MEC) 2 days ago Be among the first 25 applicants Join to apply for the
Software Quality Engineer
role at
Medical Engineering Consultants (MEC) 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 SMEs (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 software quality engineering methodologies, programs, 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 software quality goals and priorities. Provides focused software quality engineering support within new product development, operational or system/services support.
Person will be working with a Lead and team of approximately 9-10.
Key Responsibilities
Provides leadership role on championing departmental or cross-functional software development, programming, testing, validation/verification quality initiatives. Provides project direction, coaching and mentoring for engineering and technical team personnel. Proactively investigates, identifies and implements best-in-class Software Quality practices. Mentor as technical guidance for identifying and resolving software quality issues. Identifies and implements effective software quality systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements. Leads in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external software quality requirements. Acts as an effective leader or team member in supporting software quality disciplines decisions and practices. Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving software quality issues. Assures the development and execution of streamlined business systems which effectively identify and resolve software quality issues. May manage small to medium-sized projects by applying basic project management methodology e.g. project plan, schedule budget etc..
Quality Systems Duties And Responsibilities
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
9 - 11 Years with BS Engineering degree Software Engineering degree preferred MS degree with 7-8 yrs experience Has experience leading large teams in Software testing Has an understanding of Software test review process Has experience in Software test architecture Has experience in automation and manual test procedures for medical device environment Understands IEC-62304 standards in relation to Software verification and validation
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
Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
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.
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Engineering and Information Technology Industries
Business Consulting and Services Referrals increase your chances of interviewing at Medical Engineering Consultants (MEC) by 2x Get notified about new Software Quality Engineer jobs in
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Software Quality Engineer
role at
Medical Engineering Consultants (MEC) 2 days ago Be among the first 25 applicants Join to apply for the
Software Quality Engineer
role at
Medical Engineering Consultants (MEC) 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 SMEs (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 software quality engineering methodologies, programs, 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 software quality goals and priorities. Provides focused software quality engineering support within new product development, operational or system/services support.
Person will be working with a Lead and team of approximately 9-10.
Key Responsibilities
Provides leadership role on championing departmental or cross-functional software development, programming, testing, validation/verification quality initiatives. Provides project direction, coaching and mentoring for engineering and technical team personnel. Proactively investigates, identifies and implements best-in-class Software Quality practices. Mentor as technical guidance for identifying and resolving software quality issues. Identifies and implements effective software quality systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements. Leads in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external software quality requirements. Acts as an effective leader or team member in supporting software quality disciplines decisions and practices. Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving software quality issues. Assures the development and execution of streamlined business systems which effectively identify and resolve software quality issues. May manage small to medium-sized projects by applying basic project management methodology e.g. project plan, schedule budget etc..
Quality Systems Duties And Responsibilities
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
9 - 11 Years with BS Engineering degree Software Engineering degree preferred MS degree with 7-8 yrs experience Has experience leading large teams in Software testing Has an understanding of Software test review process Has experience in Software test architecture Has experience in automation and manual test procedures for medical device environment Understands IEC-62304 standards in relation to Software verification and validation
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
Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
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.
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Engineering and Information Technology Industries
Business Consulting and Services Referrals increase your chances of interviewing at Medical Engineering Consultants (MEC) by 2x Get notified about new Software Quality Engineer jobs in
Maple Grove, MN . Minneapolis, MN $125,000.00-$190,000.00 3 months ago Jr. Software Developer- GenAI - Remote US
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Eden Prairie, MN $106,579.00-$155,295.00 1 day ago Software Developer Medical Device (Onsite Maple Grove, MN) Contract
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr