Quality Engineer II

Quality Responsibilities

  • Responsible for drafting and/or updating Quality Procedures for Quality Operations functions.
  • Responsible for Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
  • Responsible for Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
  • Responsible for Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
  • Support/participate in regulatory agency and customer quality audits.
  • Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
  • Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
  • Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.

Manufacturing/Operations Responsibilities

  • Act as a Quality lead to oversee day-to-day Manufacturing activities
  • Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control.
  • Responsible for Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.
  • Provide input and expertise to manufacturing on sample sizes and statistical methods.

Design Assurance Responsibilities

  • Review and approve changes made to product and processes and validation/qualification protocols and reports
  • Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures, and training.
  • Draft, review, and maintain pFMEAs. Work with customers to draft and review dFMEAs.
  • Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.

Design Assurance Responsibilities (cont.)

  • Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
  • Develop requirements for specifying critical product requirements after collaboration with design engineering, manufacturing engineering, Customers and Suppliers.
  • Promote quality through process discipline and first-time conformance throughout the product development and manufacturing processes.

Leadership Responsibilities

  • Develop and maintains effective relationships and integrate activities with other departments and suppliers (as needed).
  • Mentor manufacturing and engineering staff on root cause techniques, problem solving, and formulation of impact assessments and justifications.
  • Identify and lead projects and initiatives to improve the quality system.
  • Coach and develop other team members.
  • Recommend and make changes to QMS procedures, SOPs, Work Instructions, and other related documents, as necessary.

Additional Requirements

  • Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
  • Good oral and written communication skills.
  • Ability to write reports, data analysis, and business correspondence.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.
  • Ability to work with mathematical concepts such as probability and statistical inference.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Experience, Knowledge and Skills

  • Statistical and data analysis skills.
  • 5+ years of work experience in the medical device industry.
  • Experience with ISO 13485, and FDA 21 CFR part 820.
  • Proficient computer skills (MS Office, Excel).
  • Excellent verbal and written communication skills. Must be detail-oriented and able to work independently.

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