Sr. Quality Engineer

Job Description

**The Client will consider only US Citizens, Green Card Holders or H1B visa transfer (they are willing to support an H1 transfer to their payroll). The Client is not open for EAD at this time.**

**This role is not open for 3rd parties!**

**Senior Quality Engineer**

**Quality Engineering Department**

**Location – Chicopee, MA – On-site position**

**Role Type Full-time position**

**Minimum 7 years of experience and related education is required!**

**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