Operations Quality Systems Engineer

100Hires, Inc.; Raynham (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

100Hires, Inc. is seeking a Quality Engineer to drive Device History Records, process validations, and CAPA investigations in a manufacturing setting in Massachusetts.

You will mentor technicians, collaborate with Design and Manufacturing Engineers, and ensure compliance with ISO, QSR, UL and other standards while leading deviation/waiver guidance and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in engineering or a related field.
• 2–5 years of Quality Engineering experience, preferably in manufacturing.
• Proficiency with quality engineering tools and techniques.
• Strong knowledge of ISO/QSR/UL/MDD/TGA regulations and standards.
• Proficient with Microsoft Office and Minitab.
• Excellent communication and collaboration skills.

Responsibilities

• Audit history records and ensure compliance with quality systems.
• Lead test method validation protocols and reports.
• Oversee manufacturing quality and provide deviation/waiver guidance.
• Lead customer complaint investigations and CAPA analyses.
• Collaborate with Design and Manufacturing Engineers on processes; coordinate validations and capability studies.
• Mentor 1–3 technicians/inspectors.

Skills

Quality engineering tools

Regulatory knowledge

Minitab

Microsoft Office

Communication

Education

Bachelor’s degree in engineering or related field

Tools

Minitab

Microsoft Office

Job description

Day in the lifeBegin your morning preparing for an upcoming audit, confirming that Device History Records for current builds are complete and correct. Midday, you are on the production floor monitoring assigned products, advising on deviations or waivers when needed, and verifying that process validations and capability studies are in motion. In the afternoon, you wrap up a customer complaint investigation, summarize CAPA trends from supplier quality and nonconforming material data, and provide clear work direction for 1–3 Technicians/Inspectors. You finish the day by reviewing proposed updates to BOMs, drawings, assembly procedures, FMEAs, and Control Plans to ensure nothing compromises compliance or product integrity.What you will doChampion our Core Beliefs while complying with all safety and quality expectations, including QMS, EMS, company policies, operating procedures, and applicable regulations.Support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.Oversee manufacturing quality for assigned products, provide deviation/waiver guidance, and ensure complete, accurate Device History Records.Assess and verify adequacy of changes to BOMs, Assembly Procedures, Drawings, Component Specifications, FMEAs, and Control Plans.Lead creation and execution of test method validation protocols and reports.Collaborate with Design and Manufacturing Engineers on new and existing product processes; coordinate process validations and capability studies; recommend process monitoring devices where appropriate.Develop and refine inspection methods and procedures to confirm conformance to design specifications.Author, approve, and implement Incoming, In-Process, and Final Inspection procedures.Ensure disposition of nonconforming materials meets regulatory requirements and that corrective actions are effective in preventing recurrence.Lead and manage customer complaint investigations.Engage in plant CAPA activities, analyzing trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.Drive continuous improvement initiatives and assist with product transfers.Partner with suppliers, management, Engineers, and Manufacturing associates to resolve quality issues; support capability studies and statistical quality control (Cpk, DOE, Hypotheses Testing, etc.).Mentor and support quality inspectors and technicians; provide work direction for 1–3 Technicians/Inspectors.Perform other functions as required; other duties as assigned.QualificationsBachelor’s degree in engineering or a related field (required).2–5 years of Quality Engineering experience, preferably in manufacturing.Proficiency with Quality Engineering tools and techniques.Strong knowledge of relevant domestic and international regulations and standards (e.g., ISO, QSR, UL, MDD, TGA, etc.).Proficient with Microsoft Office and Minitab.Effective communicator (written and verbal); able to work both independently and collaboratively.Strong time management, initiative, and work ethic.Physical requirementsNot applicablePreferred certificationsCertified Quality Engineer (CQE)Certified Software Quality Engineer (CSQE)Certified Reliability Engineer (CRE)Certified Quality Auditor (CQA)Six Sigma Green Belt or Black Belt (desired)