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Quality Engineer

3 months ago

Billerica, United States Planet Pharma Full time

Position - Prinicipal/Senior Quality Engineer

Onsite in Billerica, MA

1-year contract


Must Have

  • Ability to use statistical techniques to analyze data
  • Design of experiment/Process Characterization
  • Experience working in a fast paced Manufacturing environment
  • Validation Experience (IQ, OQ, TMV, PQ) • CAPA (Corrective Action / Preventive Action) Experience
  • Familiarity with Minitab Statistical Software

Nice To Have

  • A Bachelor in Mechanical or Electrical Engineering with ability to build custom fixtures. Ability to read drawings, BOMs, GD&T.
  • Experience in mechanical assembly and components.
  • Ability to work with vendors on dimensions and order components.
  • Ability to qualify equipment in medical device mfg. assembly line.
  • Experience in working in a med device company in a cleanroom environment.

Responsibilities may include the following and other duties may be assigned. Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.


SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.


DIFFERENTIATING FACTORS


Autonomy: Recognized expert managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager . Coaches reviews and delegates work to lower level specialists.


Organizational Impact: Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.


Innovation and Complexity: Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation . Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.


Communication and Influence: Represents organization as a primary contact for specific projects and initiatives communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement and influence decisionmaking.


Leadership and Talent Management: Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.


Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.