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Advanced product quality planning (APQP) Engineer

iTech US Inc
Andover, Massachusetts, United States
February 15, 2018

iTech US a leading global workforce management provides end-to-end solutions for customized Software Development Solutions and staffing solutions provider to Fortune 1000 firms .

Globally who trust us to design, execute and manage sophisticated workforce management solutions, large scale staffing engagements and strategic Business Process and consulting engagements.

We have Advanced product quality planning (APQP) Engineer Job in Andover, MA

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Job Title: Advanced product quality planning (APQP) Engineer

Location: Andover, MA

Duration: 6 Months Contract

Note: Required In Person Interview

Seeking for strong candidate will have medical device experience (Class I or Class II) with focus on purchasing/manufacturing /validation and should have exposure in R&D phase of project.

Primary Responsibilities

• Collaborate on continuous improvement of process and product

• Design, develop, and support package systems

• Design, develop, and support package processes

• Demonstrate high-level performance and deliver high-quality packaging

• Meet deadlines for scheduling, customer requirements, patient requirement and regulatory requirements

Required Skills & Abilities

• Bachelor's Degree in Engineering related field

• 6 years of engineering quality experience

• 3 years of Class I or Class II Medical Device quality experience

• Experience in all project phases - emphasis on R&D is preferred

• Experience in Procurement Engineering and Project Management

• Experience in Manufacturing & Advanced Product Quality Planning (APQP)

• Experience managing Supplier Quality - Inspection, Supplier Corrective Action Request (SCAR), 8D Problem Solving, CAPA, Remediation, etc.

• Knowledge of APQP Tools and Methodology - Critical to Quality (CTQ), First Article Inspection (FAI), First Production Inspection (FPI), Process Flow, PFMEA, Control Plan, Process Validation, IQ/OQ/PQ, Production Part Approval Process (PPAP), Process Capability (Cpk / Ppk), Guage R&R, DOE Analysis, etc.

• Medical experience is required - medical device preferred, but experience in other healthcare such as pharma or biotech will be considered

• Knowledge of FDA GMP standards such as 21 CFR Part 820, 21 CFR Part 11, etc.

• Good teamwork skills - ability to work well with cross-functional teams at all levels of the organization, including third parties such as suppliers, vendors, contractors and customers

• Excellent communication skills, both written and verbal

Thanks & Regards

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