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.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities 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.

Education

Preferred Minimum Technical/Advanced Degree: Technical Bachelors Degree

Experience

• Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelors Degree 1-3 Years with masters 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.

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.

The annualized base salary range for this role is $97600 - $125200 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 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.

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

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