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Quality Engineer

3 months ago

Franklin Township, United States LanceSoft, Inc. Full time

Job Title: Quality Engineer II

Location: Santa Clara CA 95054

Duration: 12 Months


Shift: 8:30 AM - 5:30 PM


What You’ll Do:

  • We are seeking an experienced, high caliber Quality Engineer II to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Each employee can make a difference and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
  • This role is an individual contributor position, requiring the candidate to have comprehensive knowledge in the specific area. Seeking a candidate who:
  • Has ability to execute highly complex or specialized projects.
  • Adapts precedent and may make significant departures from traditional approaches to develop solutions.
  • Will be responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.
  • Under general direction, has duties of instructing, directing, and checking the work of other quality assurance professionals.
  • Will be responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
  • Will conduct inspection, verification and validation of components or materials used in development processes
  • Able to identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
  • Will document quality issues and performance measures for management review.
  • May liaise with external vendors.


impact this role will.

  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Lead, coach, and mentor non-exempt and entry level exempt personnel
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Design and conduct experiments for process optimization and/or improvement
  • Appropriately document experiment plans and results, including protocol writing and reports
  • Lead process control and monitoring of CTQ parameters and specifications
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Lead the investigation, resolution and prevention of product and process non-conformances
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead in the completion and maintenance of risk analysis
  • Work with design engineering in the completion of product verification and validation


EDUCATION AND EXPERIENCE:

Required

  • BS degree in Engineering or Technical Field or equivalent experience; 2-5 years’ experience
  • Engineering experience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
  • Solid communication and interpersonal skills
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 0 - 10%
  • Ability to maintain regular and predictable attendance


Preferred

  • Advanced degree preferred
  • ASQ CQE or other certifications preferred
  • Prior medical device experience preferred
  • Experience in catheter product preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred



Employee Benefits:

At LanceSoft, full-time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)

  • Four options of Medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Other Employee Perks


About LanceSoft:

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.


EEO Employer:

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.


This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.