Sr Quality Engineer

Profile

We are seeking a Sr Quality Engineer for a very important client.

A Day in the Life
To provide quality engineering support in the design and development of innovative products through design controls planning, test method development, verification and validation. The individual shall support cross-functional development project teams and collaborate with other Company and external engineering groups to ensure that new products and product changes are adequately evaluated/tested with respect to requirements and product Design History File is complete.

Responsibilities Include:
? Evaluates product design and identifies potential design quality issues and drive technical decisions
? Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.
? Assists on-time completion of Design Control Deliverables
? Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements
? Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization
? Supports design test and inspection method development and validation
? Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
? Ensures DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
? Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
? Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
? Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
? Supports in the development and maintenance of Quality Management System procedures
? Support audits, CAPA/NCR/SCAR investigations and reports
? Perform other related duties as assigned
Requirement:
The ideal candidate will possess the following qualifications:

Must Have: Minimum Qualifications
? 4-6 years of experience with a Bachelor?s Degree in engineering discipline; or
? 2-4 years of experience with a Master?s Degree in a engineering discipline; or
? Medical or Pharmaceutical industry experience

Nice to Have
? Experience designing and testing medical device preferred
? Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
? Good statistical data analysis skills
? Design for Six Sigma and Critical to Quality training and experience a plus
? Ability to manage multiple projects across multiple geographies.
? Excellent verbal and written skills
? Able to work independently, as well as in a team environment
? Experience with 21CFR820, ISO13485, and ISO14971
? Customer focused and service oriented
? Ability to educate stakeholders, customers and management
? Ability to interface with internal customers, suppliers and regulatory agencies
? Experienced working with cross-functional and international teams
? Knowledge of FDA and TUV requirements.
? ASQ certification a plus
How to Apply:
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