Senior Manufacturing Quality Engineer

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.

Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Networks with senior internal and external personnel in own area of expertise. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

In addition to the below-mentioned responsibilities the incumbent may be asked to perform other function-related activities as reasonably required by business needs.

• Identify, diagnose, prioritize, and resolve technical and quality issues in manufacturing processes with urgency.
• Lead moderate to complex quality, manufacturing, and process improvement projects that improve product quality, efficiency, cost, and compliance.
• Analyze process control data, defects, complaints, nonconformances, and large datasets to identify trends, root causes, risks, and corrective actions.
• Own and execute complex Quality System activities, including:
  • CAPAs, HRAs/HHEs, NCEs, MRB, QSI, SCARs, Risk assessments, Complaint investigations, Planned deviations
• Author, execute, review, and coach others on:
  • TMVs, PQs, Validations, Complex change orders, Technical protocols and reports, Complaint investigation reports, SOP and procedure updates
• Ensure products and processes comply with applicable quality, regulatory, and customer requirements, including QMS, FDA Quality System Regulation, and Medical Device Directive expectations.
• Review and approve ECOs, product change orders, engineering studies, specifications, drawings, manufacturing procedures, and verification/validation documentation.
• Collaborate cross-functionally with Operations, Engineering, R&D, Manufacturing, Quality, suppliers, and external partners to resolve issues and implement improvements.
• Support audits and inspections, including facility audits, supplier audits, Notified Body audits, and FDA inspections.
• Develop, deliver, and monitor training related to procedures, investigations, and test methods.
• Mentor and coach junior engineering staff and model quality values, defect prevention, variation reduction, waste reduction, and continuous improvement.
• Communicate project status, risks, schedules, budgets, resource needs, and outcomes clearly to management and key stakeholders.

Preferred Minimum Technical/Advanced Degree:
Technical Bachelor’s Degree

• Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with master’s degree, 0-1 Years with PhD
• Experience with cleanroom processes is beneficial.
• Experience troubleshooting mechanical or electrical medical devices is preferred.

• Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
• Good technical writing skills and ability to prepare and present data
• Excellent collaboration and interpersonal skills
• Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial.
• Certified Quality Engineer is beneficial.

The annualized base salary range for this role is $97,600 - $125,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

Newark, DE, United States