Job Description
Job Description
Duties:
- Work with Design and Test Engineering in the completion of system/software requirements and other verification and validation processes.
- Review software validation protocols traceable to system/software requirements.
- Participate in meetings and provide guidance on Software Event/Defect or anomalies.
- responsible for driving the completion and maintenance of risk analysis, focused on software related risks.
- Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
- 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. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- 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.
- At least 5 years Quality Engineering experience.
- Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
- Advanced computer skills, including data analysis and report writing skills.
- Prior medical device or IVD experience preferred.
- ASQ CSQE certification desired.
- 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 timely manner.
-Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.
Looking for someone well versed in software verification and validation and risk controls/activities and trace matrix.
Company DescriptionFounded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b
Company Description
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.\r\n\r\nAt Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.\r\n\r\nKyyba is an Equal Opportunity Employer.\r\n\r\nKyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b