Senior Quality Engineer

Job Summary

Responsible to ensure all aspects of overall product quality with strong focus on continuous product/process quality improvements. Responsible for quality operational support for products manufactured in Westford and CMOs or OEMs. Makes improvements to the company quality system. High visibility role in the organization.

Essential Duties and Responsibilities

• Support the local QMS with QE support. Interpret quality data and non-conformances. Perform failure evaluations, determine root cause, and implement corrective action.  
• For product assigned, work with Operations and Manufacturing Engineering on production process flow, PFMEA and Master Validation Plan.
• Work closely with contract manufacturers on product transfers and process validations, help define in line inspection points to improve product quality, author product quality plans as needed.
• Identify process improvements for responsible product lines to improve product quality.
• Work with suppliers and contract mfgs to drive root cause investigation and appropriate corrective actions.
• Own and manage individual CAPAs. Work with cross functional team to investigate root case and drive corrective actions.
• Support risk management activities. Able to update risk management files and draft Health Hazard Evaluations as needed.
• Support the MRB evaluation process.  Represent QA on cross-function MRB committee. 
• Initiate and/or participate in cross-functional teams to support department and company goals.  Lead product quality related meetings; follow-up with team members for updates and actions; and distribute meeting minutes.
• Support Quality Control inspection group to ensure product quality is present at incoming, in-process, and at final inspection.  Establish inspection procedures and provide guidance in inspection methodology. Provide technical oversight to the QC group.
• Prepare and update Quality Assurance documents and SOPs. Review and approve interdepartmental records, documents and SOPs to ensure conformance with the regulations and guidelines.
• Support internal and external audits with backroom or front room support as needed.
• Must be team player, willing to contribute and collaborate to drive departmental goals.
• Embody and deliver the “Exceptional Everyday”

Qualifications 

Education

☒ Bachelor’s degree required

 Specific Area of Study: Bachelor’s degree in Electrical, Mechanical or Optical Engineering preferred.

Experience

☒ 5 to 8 years relevant experience

Specific Related Experience: 5 + years of experience in quality, product development or process development within FDA and/or ISO 13485 regulated medical device setting, with hands on knowledge of regulations with minimum of three (3) years in quality is required. Experience in medical devices manufacturing; experience with software driven electro-mechanical medical devices highly preferred.

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification desired.
• Previous experience supporting capital equipment and sterile products.

 Skills

• Ability to read, analyze and interpret international and national Quality standards.
• Ability to effectively communicate and present information to top management and auditors from various compliance agencies. 
• Ability to communicate efficiently and effectively with all levels within Quality as well as cross functionally with departments such as Manufacturing, Engineering and Purchasing.
• Proficient in the areas of statistical principles and applications; qualitative and quantitative data analysis; DOE, Acceptance and Sampling; process improvement/optimization; gage R&R measuring systems; and system and product audit.
• Proficient in manufacturing and quality documentation development.
• Ability to work independently or under minimal supervision.
• Understanding of manufacturing processes, challenges, and solutions.
• Knowledge of Microsoft Word and Microsoft Excel.
• Working knowledge of statistical programs (Minitab or other statistical packages).
• Knowledge of ISO standards for Class II medical devices preferable (ISO 13485, 14971).
• Working knowledge of electronic quality management systems and/or manufacturing execution (ERP) systems.
• Exceptional analytical, electronics and electromechanical aptitude, problem solving, and root-cause analysis skills.
• Excellent organizational skills.
• Strong written and verbal communication skills.