• Job Description

  Req#: 25-236134

  We are seeking a highly skilled candidate for an immediate opening to backfill an employee during a mandatory time-off period. This is a short-term position lasting 3 months, with responsibilities across multiple projects impacting various product lines.

  Must Have

  • Bachelor's degree in Engineering, Science, or a technical field with a minimum of 4 years of experience in Engineering and/or Quality, or an advanced degree with 2 years of relevant experience.
  • Experience in Validation/Qualification activities: writing, coordinating, executing, creating reports, IQ, OQ, PQ, MVPR, etc.
  • Experience in Risk Documentation: writing, reviewing, approving Risk Management files, RPM calculations, Risk Mitigations, etc.
  • Strong statistical background and sampling size determination for attribute or variable data.
  • Ability to work with minimal supervision in a hybrid working setup.
  • Excellent writing, documentation, organizational, and verbal communication skills.
  • Ability to work in a fast-paced environment and meet deadlines.
  • Ability to interact with a diverse team while maintaining high ethical standards.
  • Commitment to the company's core values.
  • Strong Risk Management Experience.

  Nice to Have

  • ASQ Quality Engineer Certification.
  • Bilingual in English/Spanish preferred but not required.
  • Previous experience in the medical device industry.
  • DMAIC Lean / Six Sigma Certification.
  • Manufacturing experience within a controlled and regulated industry.

  Responsibilities

  • Provide Quality Engineering support to multiple projects, including supplier quality engineering support.
  • Conduct day-to-day Risk Management reviews and maintain strong Risk Management practices.
  • Develop, execute, analyze, and report on validation/qualification activities such as IQ, OQ, PQ, MVP, and Test Method Validations.
  • Evaluate, review, and update quality records, including design files and process documents, ensuring compliance with ISO standards and local procedures.
  • Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal and external standards.
  • Provide expertise and guidance in interpreting policies and regulations to assure compliance.
  • Work with various internal and external entities to provide quality engineering and supplier quality engineering support.
  • Prepare reports and necessary documentation for project stakeholders.
  • Develop and apply quality standards and protocols for material processing.
  • Implement inspection, testing, and evaluation methods for product precision and accuracy.
  • Ensure corrective measures meet reliability standards and documentation requirements.
  • Support multiple projects in areas such as design, production control, and research and development.
  • Perform Root Cause Investigation using quality tools when required.
  • Collaborate with cross-functional teams to resolve process issues and implement changes.
  • Apply process control tools and statistical sampling techniques to enhance product quality and flow.
  • Identify, analyze, and manage risk throughout the product life cycle using risk management tools.

  Differentiating Factors

  Autonomy: Operates independently under limited supervision, coaching lower-level specialists and potentially managing projects.

  Organizational Impact: Responsible for projects or processes, contributing to work group objectives through collaboration and consensus building.

  Innovation and Complexity: Solves complex problems, improves processes, and provides in-depth analysis with recommendations.

  Communication and Influence: Communicates with senior internal and external stakeholders, exchanging information to achieve objectives and influence decisions.

  Leadership and Talent Management: Provides guidance and training to other employees, manages projects, and delegates work as needed.

  Required Knowledge and Experience: Requires advanced knowledge of the job area, typically obtained through an advanced education combined with experience. Practical knowledge of project management is beneficial. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

• About the company

  Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

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