Sr. Product Quality Engineer

Harmonic Drive; Beverly (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Harmonic Drive LLC is seeking a Quality Engineer to assist in examining components, processes, and documentation to ensure top quality products. You will lead MRB activities, analyze metrics and collaborate with development teams to meet QMS requirements.

The ideal candidate has 5+ years in engineering within regulated environments, strong statistics, GD&T expertise, and solid MS Office/Minitab skills. The role is on-site in Beverly, MA with standard day hours.

Qualifications

• 5+ years of engineering experience in ISO/FDA-regulated environments.
• At least 3 years in a direct quality role.
• Strong statistical methods (MSA, capability analyses, DOE) proficiency.
• Experience with GD&T and measurement systems.

Responsibilities

• Lead MRB activities and metrics distribution.
• Lead investigations of nonconformities and corrective actions.
• Use analytical methods to assess product/process performance.
• Participate in regulatory/customer audits.
• Conduct internal QMS and manufacturing audits.
• Participate in supplier evaluation and corrective actions.
• Perform risk assessment including FMEA and control plans.
• Ensure QMS documentation, change control, CAPA and training compliance.
• Collaborate with Product Development to meet customer/QMS requirements.

Skills

Communication skills

MS Office proficiency

Education

Bachelor's degree in engineering

Tools

Minitab

Excel

PowerPoint

Job description

Summary / Objective

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

Essential Functions

• Lead MRB activities and coordinates, collects, analyzes and distributes quality monthly and quarterly metrics.
• Lead investigations of manufacturing nonconformities and assist manufacturing in implementing effective corrective actions
• Uses analytical methods to assess product and process performance and quantify the effect of changes
• Participates in audits conducted by regulatory agencies and/or customers.
• Conducts internal QMS and manufacturing processes audits.
• Participates in supplier evaluation and selection process. Works with supplier to address supplier related nonconformities.
• Participates in risk assessment and risk management activities including FMEA and development of control plans
• Ensures compliance and operational effectiveness in all areas of the QMS including document control, 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.

Competencies

Required

• Bachelor's degree in an engineering discipline with excellent written and oral communication skills.
• 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
• Experience with mechanical measurements and understanding of GD&T.
• Experience with 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 industries.

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.

Work Environment

This job operates in a manufacturing environment. This role routinely uses shop floor tools and measuring equipment

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Manual dexterity sufficient to operate measuring equipment for precision work
• Visual acuity (corrected) to read directions and prints and to inspect machined parts closely to ensure that they meet specifications
• Frequently required to sit, stand, move about the shop floor, talk, hear, bend and reach with hands and arms
• Occasionally lift and/or move up to 50 pounds
• Ability to squat or kneel occasionally

Position Type/Expected Hours of Work

This is a full-time position, and hours of work and days are Monday through Friday, 7:00am to 3:30pm.

Travel

None

Required Education and Experience

• Minimum of 5 years of overall Engineering experience in an ISO (FDA is a plus) regulated environment, with at least 3 years in a direct Quality role is required
• College degree is preferred but not required (5 years with degree/10 years without)

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

*Harmonic Drive LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.*

*This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.*

*U.S. Export Controls Requirements: This job may require access to technology, materials, software or hardware that is controlled by the export laws of the United States. Candidates are required to provide proof of either US citizenship, Permanent US residency or classification as a protected individual as defined in 8 USC 1324b (a) (3).*

*This position is not eligible for immigration sponsorship.*