Job Title

Product Quality Engineer 3

Job Description

Product Quality Engineer 3

The Product Quality Engineer 3 will work primarily with Product Industrialization Engineering and R&D in support to the manufacturing Product Transfers, NPIs and Design Changes, additionally will provide support of product inspections, and product and process compliance to established procedures and will take corrective and preventive action as required by procedures to support the continued operation of the Costa Rica. Also will provide coaching and guidance to Product Quality Engineers 1 and 2 for PQE topics related to Risk Management, Process Validation, Quality Planning, CAPA, NCR, Design Changes, and other PQE related topics. Lead a group of direct report (Quality Technicians or Engineers) as required.

You are responsible for:

• Responsible for leading SW quality engineering activities like:
• Designing SW Quality plans, overseeing the execution of SW Quality Plans, assessing complex software designs and reviewing test and other complex performance data, analyses market feedback.
• Lead complex root cause analysis and complex SW Quality problem solving.
• May also provide other SW Quality engineering support, including assisting organizational units in leading resolution of SW Quality engineering deficiencies.
• Seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Frequently interacts with subordinate engineers customers, and/or functional peer group normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team.
• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Implements strategic improvements when selecting methods, techniques, and evaluation criteria for obtaining results.

To succeed in this role, you’ll need a customer-first attitude and the following:

• Bachelor’s degree in engineering disciplines or related field or a combination of equivalent job experience in related field.
• Advanced English skills
• 7 years of experience in Quality or Manufacturing or other related fields Desirable or a combination of equivalent job experience in related field
• Working knowledge of appropriate global medical device or consumer product
• regulations, requirements, and standards.
• Proven knowledge and application of applicable regulations for Medical Device manufacturing.
• Proven ability to understand and interpret established quality system requirements and provide advice to project teams and the organization in general on how to remain compliant to requirements during execution

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