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Hardware Quality Engineering is responsible for participating in product development teams to support all quality aspects of design, development, and design transfer to manufacturing including supplier selection and qualification.
Job Family Descriptors
Applies working knowledge of quality engineering concepts and test methods within the product lifecycle
Understanding of test protocol structure and requirements.
Applies basic knowledge of end user into test protocol
Ability to select appropriate test methods and to develop test protocols and execute them.
Ability to perform statistical analysis of results.
Determines that quality objectives and goals have been identified and are sufficiently defined in specifications, procedures, and testing
Ability to document / review documents to support DHF
Ability to provide feedback to the company as to if the documentation meets the need
Has in-depth experience, knowledge and skills in own job family
Applies knowledge and skills to a wide range of standard and non-standard situations
Works independently with minimal guidance
Usually determines own work priorities
Acts as a resource for colleagues with less experience
Bachelor's degree in related field required
4+ years related work experience required
Ability to train and coach others from technical expertise
As directed by the Quality Manager, the Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
In order of importance, describe 4 to 6 of the primary responsibilities and duties. In Sections 3 and 4, describe how the position aligns to the job grouping criteria of Scope of Responsibilities and Impact on Business Results.
% of Time (estimated) Responsibilities: Each responsibility is a grouping of tasks/duties. Do not create a list of individual tasks. Generally each position has 4 to 6 responsibilities. See the Guidance Document for examples of responsibilities.
Consistent application of technical principles, theories, concepts and quality sciences / tools.
Proven problem solving skills
Makes measureable improvements to Client processes and procedures
Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
5 Is a team member representing Quality on new product development and sustaining engineering projects.
6 Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
7 Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training)
Strategic Orientation: Describe the degree to which the position has responsibility for influencing and/or developing strategies for achieving company goals and examples.
Specific scope of responsibilities is to be based on the specific role
Contributes to the completion of specific programs and projects.
Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers
May be expected to make presentations
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