Senior Quality Engineer: ISO/GMP & Process Improvement

Harmonic Drive L.L.C.; North Beverly (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Harmonic Drive L.L.C. is seeking a Quality Engineer to assist in examining components and processes to ensure the highest quality products for customers.

The role focuses on leading MRB activities, investigations of nonconformities, and applying statistical methods to improve performance. The ideal candidate will have a Bachelor’s in engineering, experience with MSA/DOE, GD&T, and ISO 9001/AS 9100 environments, plus strong communication skills.

Qualifications

• Bachelor's degree in engineering; good written and oral communication.
• Experience with statistical methods including MSA, process capability analyses, and DOE.
• Proficient with Microsoft Word, Excel & PowerPoint; Minitab or other statistics software.
• Experience with mechanical measurements and understanding of GD&T.
• Experience with leading improvement projects in manufacturing and documenting processes/procedures.
• Experience with ISO 9001, AS 9100 or other regulated industries.

Responsibilities

• Lead MRB activities and coordinate quality metrics.
• Investigate manufacturing nonconformities and support effective corrective actions.
• Use analytical methods to assess product/process performance and quantify changes.
• Participate in audits by regulatory agencies and customers.
• Conduct internal QMS and manufacturing process audits.
• Participate in supplier evaluation and resolve supplier nonconformities.
• Contribute to risk assessment and risk management including FMEA and control plans.
• Ensure compliance and effectiveness of QMS and document/change control.

Skills

Engineering degree

Statistical methods

Minitab

GD&T

Process improvement

ISO knowledge

Education

Bachelor's degree in engineering

Tools

Minitab

Microsoft Office

Job description

Harmonic Drive L.L.C. is seeking a Quality Engineer to assist in examining components and processes to ensure the highest quality products for customers.

The role focuses on leading MRB activities, investigations of nonconformities, and applying statistical methods to improve performance. The ideal candidate will have a Bachelor’s in engineering, experience with MSA/DOE, GD&T, and ISO 9001/AS 9100 environments, plus strong communication skills.