Sr. Quality Engineer

2 months ago

Tempe, United States MillenniumSoft Full time

Roles & Responsibilities

Other Responsibilities may include, however are not limited to:
Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.
Ability to make and present risked based decisions
Prepare and present project updates and technical discussions
Technical leadership skills including an understanding of medical device operations (, medical device manufacturing, process development, quality assurance)
Leads development of risk assessments and test methods
Leads component qualifications, design validation / verification and process validation
Leads product investigations
Assess product changes against product design
Supports translation of design inputs into manufacturing control plans
Prepare and present project updates and technical discussions
Provide support to the regulatory department in writing technical submissions
Complies with company procedures and policies, government regulations
Other duties and projects, as assigned

Experience Required

Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Skills & Certifications

Required Qualifications:
Knows how products are used and impact the user(s) so that risk can be managed effectively Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to lead creation of risk management files Ability to develop solutions with business impact Advanced statistical and risk assessment techniques Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to Lead cross functional teams Understanding of regulatory requirements including ISO 13485, ISO 14971

Eligibilities & qualifications

Preferred Qualifications:

Quality Engineering Certification (ASQ) or equivalent Education and/or Experience: BS in Engineering

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