Senior Manufacturing Quality Engineer
Essential Duties and Responsibilities
- 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.
Education
A preferred minimum technical/advanced degree is a Technical Bachelor’s Degree. Experience with cleanroom processes is beneficial. Experience troubleshooting mechanical or electrical medical devices is preferred.
Experience
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.
Knowledge
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.
Why Join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
Compensation
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.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.