Senior Quality Engineer

3 days ago

New Haven, Connecticut, United States LanceSoft Full time
Job Description

The Senior Quality Engineer is responsible for developing and executing the supplier quality strategy for the AST stapling business platform. This includes representing the quality engineering function, managing supplier selection and qualification, and reviewing technical quality documentation.

Key responsibilities include:

  • Leading PPAP qualifications with clients
  • Collaborating with clients to develop robust SCAPAs
  • Supporting the quality team to develop and improve an effective supplier quality process
  • Working with new and existing clients to develop, implement, and maintain technical quality assurance systems and activities
  • Managing supplier corrective action requests and ensuring compliance with business quality systems

The ideal candidate will have a Bachelor's Degree in an Engineering or Scientific field and a minimum of 5 years of experience in a supplier quality or quality engineering function.

This is a full-time position with a 40-hour workweek. The contractor will be required to work onsite with some flexibility to work remotely.

The timeline for scheduling interviews is July 1st. The product line supported by this position is the AST stapling platform.

Additional Responsibilities

The Senior Quality Engineer will be responsible for:

  • Leading by example and setting a continuous-improvement driven mentality and solid quality culture for the organization
  • Maintaining compliance to set Key Performance Indicators for the business
  • Managing and reporting on client/supplier audit programs in line with ISO and/or FDA 21 CFR part 820 regulations
  • Translating engineering, manufacturing, and quality requirements for CM products
  • Performing deviation investigations into quality issues arising from CM activities

The Senior Quality Engineer will work closely with the quality team, engineering, and manufacturing functions to ensure quality standards are in place and that corrective measures meet acceptable reliability standards.

Requirements

The ideal candidate will have:

  • Advanced knowledge of the job area combining breadth and depth, typically obtained through advanced education combined with experience
  • Practical knowledge of project management
  • A University Degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience

Specialist Career Stream

This is a specialist career stream position, typically an individual contributor with responsibility in a professional discipline or specialty. The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Autonomy

The Senior Quality Engineer will work independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.

Organizational Impact

May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity

Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence

Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management

May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

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