Sr. Product Quality Engineer

Harmonic Drive L.L.C. • Beverly, MA

7d

About The Position

The Sr. Product Quality Engineer assists with examining and approving components, finished products, equipment, processes, and related documentation. Using a range of tools and techniques, the role helps ensure that high-quality products are delivered to customers. The position works across manufacturing, supplier quality, product development, and the Quality Management System (QMS), and has no direct reports.

This full-time position is based in a manufacturing environment and routinely uses shop-floor tools and measuring equipment. The scheduled hours are Monday through Friday, 7:00 a.m. to 3:30 p.m.; travel is not required. The position may require access to items controlled by U.S. export laws. Candidates must provide proof of U.S. citizenship, permanent U.S. residency, or protected-individual status as defined in 8 USC 1324b(a)(3). Immigration sponsorship is not available.

Requirements

• At least 5 years of overall engineering experience in an ISO-regulated environment, with at least 3 years in a direct quality role.
• Experience with statistical methods, including measurement system analysis (MSA), process capability analyses, and design of experiments.
• Proficiency with Microsoft Word, Excel, and PowerPoint, and Minitab or other statistical software suites.
• Experience with mechanical measurements and understanding of GD&T.
• Experience leading improvement projects in a manufacturing environment and writing and implementing processes and procedures.
• Experience with manufacturing processes in an ISO 9001, AS 9100, or other regulated industry.
• Excellent written and oral communication skills.
• The posting gives conflicting education guidance: it lists a bachelor's degree in an engineering discipline as required, while later stating that a college degree is preferred but not required, with 5 years of experience with a degree or 10 years without.

Nice To Haves

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

Responsibilities

• Lead material review board (MRB) activities and coordinate, collect, analyze, and distribute monthly and quarterly quality metrics.
• Lead investigations of manufacturing nonconformities and assist manufacturing in implementing effective corrective actions.
• Use analytical methods to assess product and process performance and quantify the effect of changes.
• Participate in audits conducted by regulatory agencies and/or customers.
• Conduct internal QMS and manufacturing-process audits.
• Participate in supplier evaluation and selection, and work with suppliers to address supplier-related nonconformities.
• Participate in risk assessment and risk-management activities, including FMEA and development of control plans.
• Ensure compliance and operational effectiveness across QMS areas, including document control, change control, training, complaint handling, CAPA, nonconforming processes, and internal and external auditing.
• Collaborate with Product Development to ensure project designs, procedures, and outcomes meet customer and QMS requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior