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Sr. Quality Engineer

Beverly, MA 01915

Posted: 09/14/2023 Job Number: 32999

Job Description

The primary responsibilities for the Sr. Product Quality Engineer include assisting in examination and approval of components and finished products, equipment, processes and related documentation. Utilizing different tools and techniques, the Sr. Product Quality Engineer will help ensure that only products of the highest quality are delivered to our customers.

Essential Functions
  •     Lead MRB activities to include coordination, collection, analysis and distribution of   monthly and quarterly quality metrics.
  •     Lead investigation of manufacturing nonconformities and assist in developing and implementing effective corrective actions
  •     Apply analytical methods to assess product/process performance and quantify the effect of the change.
  •     Conduct internal QMS and manufacturing processes audits and participates in various internal and external 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
  •     Participate in supplier evaluation and selection process working with supplier to address supplier related nonconformities.  
  •     Participate in risk assessment/management activities (i.E. FMEA) and the development of control plans
  •     Ensure compliance and operational effectiveness in all areas of the QMS including change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external).
  •     Collaborate with Product Development to ensure designs, procedures and outcomes are meeting customer and QMS requirements.
  •     Adhere to safety, environmental, and quality-related policies and procedures in the facility.



  •     Demonstrated proficiency in;
    •     Leading teams and projects using a fact-based problem-solving methodology (DMAIC or 8D). 
    •     Basic metrology and GD&T

o    Applying quality problem-solving methods like FMEA, SPC, control plans, etc.

o    Working independently and collaboratively when making decisions.

o    Analytical thinking, attention to detail, problem-solving, and failure analysis aptitude

·         Experience with

o    Statistical methods (i.E, MSA, process capability analyses, experiment design).

o    Developing, writing and implementing processes and procedures.

o    Manufacturing processes in an ISO 9001, AS 9100 or other regulated industries.

·         Strong data management, synthesis, and interpretation capabilities.

·         A strong quality mindset with the ability to handle tight deadlines, and manage multiple priorities.

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

Required Education and Experience
  •     Bachelor's degree in an Engineering discipline
  •     Minimum of 8 years of overall Engineering experience in an ISO (FDA is a plus) regulated environment
  •     Minimum of 5 years in a direct Quality role is required


·         Proficient with Microsoft Word, Excel & PowerPoint. Minitab or other statistical software suites 

Meet Your Recruiter

Fran Hardy

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