Senior Quality Engineer

Quality Engineering Department

Location - Chicopee, MA - On-site position

Role Type Full-time position

About Our Client

Our client is an established manufacturing company specializing in sealed plastic film products for multiple industries, with a particular focus on medical device manufacturing. Operating in an ISO 13485 certified environment, they maintain the highest standards of quality and regulatory compliance. The company serves diverse markets requiring stringent quality controls and has built a reputation for excellence in manufacturing processes and quality management systems. Their commitment to continuous improvement and regulatory adherence makes them a trusted partner in industries where product quality and safety are paramount.

Job Description

The Senior Quality Engineer will play a critical role in developing and implementing comprehensive quality systems for sealed plastic film products within our client's ISO 13485 environment. This position requires a quality professional who can ensure products meet the most stringent quality and regulatory requirements across multiple industries, particularly medical devices. The successful candidate will collaborate closely with cross-functional teams, including Quality Technicians, production staff, and various support departments to maintain excellence in quality management systems.

The role offers the opportunity to directly impact product quality and customer satisfaction while working with cutting-edge quality management methodologies. This position is ideal for a quality engineering professional who thrives in a regulated environment and is passionate about implementing robust quality systems that drive continuous improvement and regulatory compliance.

Duties and Responsibilities

• Oversee and approve IQ, OQ, PQ validation protocols, execution and reports on new and sustaining products
• Oversee PPAP activities and produce PPAP submittal packages on new and sustaining products
• Collaborate with Quality Technicians to resolve quality issues
• Participate as a member of the FMEA team related to primarily new and developing products
• Develop and document control plans
• Conduct statistical capability studies and set up SPC control charts
• Document inspection procedures and test methods
• Perform regular audits of processes and materials to ensure compliance with specifications and standard operating procedures
• Finalize release of finished product based on audit results
• Monitor and interpret SPC charts to ensure processes remain in control
• Interface directly with production in the operator training process for quality issues
• Review reject reports and initiate corrective action as required
• Interface directly with other support departments as required
• Conduct special testing when required for failure analysis, validations, etc.
• Set up inspection and test equipment
• Develop and maintain Standard Operating Procedures
• Develop protocols, perform statistical analyses and write reports for validations and formal product/process development
• Review and document procedure changes for quality requirements and compliance with the quality system
• Provide audit support for third party audits, customer audits, and internal audits

Required Experience/Skills

• 4-year college degree in related field and 7+ years' experience in a Quality Engineering Role (preferably in medical device manufacturing) or equivalent combination of education and experience
• 7+ years' experience in validation activities (IQ, OQ, PQ, MSA), PPAP packages, FMEA/PFMEA activities, Root Cause Analysis/CAPA, Internal Quality Audit, Supplier Quality, and Software Validation
• Good working knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology SPC, and Good Manufacturing Practices
• Proficiency in the use of Productivity Software such as Microsoft Office
• Ability to interact with all levels of the organization and with suppliers
• Strong written and oral communication skills
• Strong analytical skills in problem analysis and problem solving
• Strong leadership skills

Nice-to-Haves

• ASQC Certified Quality Engineer certification
• Experience in sealed plastic film or similar manufacturing environments
• Previous experience in medical device manufacturing
• Knowledge of additional quality management systems and regulatory frameworks

Education

4-year college degree in Engineering, Quality Management, or related field required

Call-to-Action

Ready to take your quality engineering career to the next level? Join our client's team and make a direct impact on product quality and customer satisfaction in a dynamic manufacturing environment. Apply today to become part of a company that values excellence, continuous improvement, and regulatory compliance!

Apply Now!

Keywords: Quality Engineer | Medical Device | ISO 13485 | PPAP | FMEA | Validation | SPC | Quality Management | Manufacturing | Regulatory Compliance | Root Cause Analysis | CAPA