Quality Engineering Senior

Position: Sr. Quality Engineer

Location : Tempe, AZ

Duration : 6+ Months contract

Total Hours/week: 40.00

1st Shift: Shift 8 am to 5:00 pm

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

Onsite

• Must haves on the resume: Validation experience, 2 years exp in med device

Job Description

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

EU-MDR submissions: leads Quality activities surrounding EU-MDR submission of products. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals. Project Management: Assists with creating strategic plans and budgets for EU-MDR. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements. Design to Manufacturing Transfer: supports product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing. Test Method Development & Validation: leads the development and validation of clinically relevant test methods that adequately challenge product design and processes. Testing: Leads verification and validation activities for products and processes in support of EU-MDR requirements.

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 (e.g., 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

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

Preferred Qualifications:

Quality Engineering Certification (ASQ) or equivalent

Education and/or Experience:

BS in Engineering

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.