Senior Supplier Quality Engineer

Are you passionate about driving supplier excellence and ensuring compliance in a fast-paced global environment Hologic is seeking a Senior Supplier Quality Engineer to support our Global Supplier Quality organization ensuring that components materials and services from suppliers consistently meet stringent quality and regulatory requirements.

In this role youll assess and qualify suppliers oversee their manufacturing and quality practices resolve supplier nonconformances and lead datadriven improvements using tools like PPAP SPC GR&R and CAPA. Youll partner closely with R&D Design Assurance PostMarket Manufacturing and global suppliers to protect product quality reliability and patient safety. If you enjoy technical problem solving supplier collaboration and being a key gatekeeper for incoming quality in a regulated environment this role is for you.

• Strong working knowledge of medical device and IVD regulations including:
  • cGMP
  • 21 CFR 820 (QSR)
  • ISO 13485 ISO 14971 ISO 9001
  • MDR/IVDR and other global regulations (e.g. FDA Canada Brazil Japan).
• Deep familiarity with supplier quality management practices including qualification performance monitoring and escalation.
• Understanding of PPAP (Production Part Approval Process) concepts and requirements (desirable).
• Knowledge of validation (IQ OQ PQ) risk management and CAPA processes as they relate to suppliers.
• Strong grasp of metrology measurement systems analysis (MSA including GR&R) and quality records requirements.

• Ability to execute and maintain supplier quality processes in accordance with the Quality Management System and regulatory standards.
• Skilled in conducting technical reviews of suppliers to assess their capability to manufacture materials/components to specification.
• Experience overseeing and monitoring suppliers for:
  • Manufacturing and process controls
  • Quality control practices
  • Corrective actions and continuous improvement
  • First Article Inspection (FAI)
• Ability to define approve and follow up on PPAP requirements for new and revised purchased parts.
• Proficient in issuing and managing SCARs SACAs and NCEs in systems like Agile and tracking workflow timing against KPIs.
• Strong problemsolving skills including use of SPC statistical sampling root cause analysis and CAPA to prevent repeat failures.
• Experience working crossfunctionally with Post Market Surveillance Quality Engineering Manufacturing Engineering R&D and other teams to address supplierrelated complaints and issues.
• Capable of managing daytoday supplier nonconformities (containment disposition returns rework sorting sample management).
• High proficiency with Microsoft Office for reports data analysis and presentation of supplier performance metrics.
• Experience with ERP systems and updating supplier status and approvals for materials.
• Knowledge of project management techniques and ability to handle multiple complex projects concurrently.
• ISO 13485 Lead Auditor capability is a strong plus.

• Strong clear communicatoreffective in written and verbal communication with internal stakeholders and suppliers at all levels.
• Analytical and objective able to evaluate data and translate it into meaningful proposals action plans and improvements.
• Highly organized able to manage multiple suppliers projects and issues simultaneously.
• Collaborative and solutionoriented building constructive relationships with global suppliers and internal teams.
• Selfdriven and able to work both independently and as part of crossfunctional teams.
• Qualityfocused consistently applying riskbased thinking and regulatory requirements to supplier decisions.

• Bachelors degree in Engineering (e.g. Plastics Mechanical Electrical Mechatronics or other relevant discipline).
• ASQ Supplier Quality Engineer certification is a plus.
• Minimum 5 years of professional experience with a Bachelors degree in roles with similar responsibility decisionmaking and problem solving.
• Recognized expertise in supplier quality or a closely related function within a regulated or manufacturing organization.
• Experience in a medical device or IVD environment strongly preferred.
• Experience supporting internal and external audits as a Subject Matter Expert for supplier quality; willingness to travel domestically and internationally for supplier visits and audits.

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 $98500-$154000 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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