Salary : Contact Employer
City : Plymouth
Job type : Full-time
Job skills : Engineering Support, Training, Software Development, Design, Manufacturing, Manufacturing Engineering, Verification, Controlling, Defect Tracking, Maintenance, Risk Analysis, Analysis, Process Improvement, Lean Manufacturing, Resolving Issues, Management, Quality Management, Environmental Management, Communications, Data Analysis, Report Writing, Writing, Information Technology, Data Mining,
Job titles: Software Quality E
Job Description
- Position: Software Quality Engineer
- Location: Plymouth, MN
- Shift: 8 AM : 5 PM
Work with Design and N Manufacturing Engineering in the satisfaction of structure/programming necessities and other check and endorsement frames.
Duties:
Make and execute or coordinate programming approval conventions traceable to framework/programming prerequisites.Create and direct preparing of organization work force for the divisional programming advancement and approval program.
Actualize answers for controlling code and direct Code Control and Software Event/Defect Tracking programming frameworks.
Assist in the completion and maintenance of risk analysis, focused on software related risks.
Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
Apply sound, systematic problem:solving methodologies in identifying, prioritizing, communicating and resolving issues.
Work with Design and N Manufacturing Engineering in the culmination of framework/programming prerequisites and other confirmation and approval forms.
Software scoping and Part 11 audits.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Qualifications:
- BS Degree in Engineering or Technical Field or equivalent experience.:2:5 years of Software Quality Engineering experience.
- Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
- Advanced computer skills, including statistical/data analysis and report writing.
- Advanced Information Technology and data mining skills.
- Prior medical device experience preferred.
Experience working in a broader enterprise/cross:division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast:paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks prioritizes and meets deadlines in a timely manner.
Strong organizational and follow:up skills, as well as attention to detail.
Ability to travel including internationally.
Ability to maintain regular and predictable attendancepany Description
TEKWISSEN Group is an Equal Opportunity/Affirmative Action Employer (M/F/Disability/Veterans).
We will consider all applications without regard to race, gender, sexual orientation, gender identity, age, color, religion, national origin, veteran status, disability, genetic information or any other status protected by applicable law.:ul
The key roles this job posting is looking for are Process Design, Object Oriented Design, Computer Engineering.
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