Sr. Product Quality Engineer

3 weeks ago

Beverly, United States Careerbuilder-US Full time

Pay range $100K- 110K
Essential Functions

  • Lead investigations of manufacturing nonconformities and assist manufacturing in implementing effective corrective actions
  • Participates in audits conducted by regulatory agencies and/or customers and conducts internal QMS and manufacturing processes audits.
  • Apply statistical process control (SPC) methods to evaluate current processes and process changes
  • Collaborate and support company-wide CAPA and non-conformance implementation and continuous improvement projects
  • Participates in supplier auditing, evaluation and selection process. Works with supplier to address supplier related nonconformities.
  • Participates or lead risk management activities including FMEA and development of control plans
  • Ensures compliance and operational effectiveness in all areas of the QMS including change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external).
  • Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are meeting customer and QMS requirements
  • Collaborate with cross-functional teams to establish and maintain quality control processes and procedures
  • Monitor and track key quality metrics, creating reports to identify trends and areas for improvement
  • Adhere to safety, environmental, and quality-related policies and procedures in the facility.
  • Performs other duties as required.
  • Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines.
  • Demonstrated proficiency in basic metrology and GD&T.
  • Proficiency in applying quality problem-solving methods like FMEA, SPC, control plans, etc.
  • Analytical thinking, attention to detail, problem-solving, and failure analysis aptitude
  • Possess a strong quality mindset, ability to handle tight deadlines, and manage multiple priorities.

Competencies
Required:

  • Bachelors degree in an engineering discipline with effective communication and interpersonal skills for establishing relationships internally and externally
  • Experience with statistical methods including MSA, process capability analyses, and design of experiments.
  • Proficient with Microsoft Word, Excel & PowerPoint, Minitab (or other statistical software suites)
  • Demonstrated proficiency leading teams and projects using a fact-based problem-solving methodology (DMAIC or 8D).
  • Experience with developing, writing and implementing processes and procedures.
  • Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter.
  • Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers

Desired:

  • ASQ certified Quality Auditor and/or Quality Engineer.
  • Lean Six Sigma Green or Black Belt.
  • Experience in a Good Manufacturing Practice (GMP) environment.

Supervisory Responsibility
This position has no direct reports.

Required Education and Experience

  • Minimum of 8 years of overall Engineering experience in an ISO (regulated environment, with at least 5 years in a direct Quality role is required
  • College degree or equivalent is required.

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