Job Summary

This position supports the overall Global Supply Chain Quality organization dedicated to the oversight of Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) suppliers. The Supplier Quality Engineer (SQE) would work on a range of products in Hologic’s Diagnostics Division to ensure suppliers are capable and meeting all requirements. Through a positive relationship build with effective lines of communication with the CMs and OEMs; the SQE works with the CMs and OEMs on improvement projects involving multi-functional areas, assuring compliance to the different applicable regulations and standards. 

 Responsibilities

 Adhere to and support the company policy and QSR/ISO Quality System requirements  Be the face of Hologic Quality with Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) suppliers  Ensure compliance with the regulatory standards and the requirements established in the quality system by suppliers through periodic audits. Perform monitoring of activities, corrective / preventive actions, NCEs, metrics, maintenance of supplier files. Lead, coordinate and supervise the areas under his/her responsibility and balance the amount of existing work to comply with the goals established by the organization. Support preparation/execution of budget forecasts and ensure compliance with the approved budget. Support the Supplier Audit program as needed. Manage supplier change notifications and supplier change requests to ensure that changes are recorded, communicated to stakeholders, and addressed appropriately. Follow Corporate procedures to implement standard/harmonized Supplier Quality Assurance processes globally which includes CM’s & OEM’s supplier qualification, certification, assessment, monitoring, production part approval process (PPAP), performance management and quality issues’ resolution  Participate as a member of the Material Review Board and the dispositioning of nonconforming product and components. Interface with Contract Manufacturers (CM’s) and Original Equipment Manufacturers (OEM’s) in resolving applicable Quality Issues and driving appropriate Corrective and/or Preventive Actions. Monitor quality metrics (e.g. field complaints, manufacturing and inspection) and key process indicators to identify opportunities for improvement at the supplier and Hologic; and partners with different areas stakeholders to drive actions. Identifies unacceptable trends and applies suitable corrective action with the respective CM / OEM, to meet strategic objectives. Support the implementation of design changes that may impact the CM / OEM product and process. Review and approve Contract Manufacturer process validation test plans, protocols, and reports, as per the supplier and Hologic procedures. Ensure validation results demonstrate compliance to medical device standards as applicable. Review test methods for quality of verification and validation of the method used at the supplier premises  Execute appropriate level of Part/Process Qualification with Contract Manufacturers and/or OEM’s. Support Continuous Improvement activities to drive Supplier Development in support of cost savings and increased Quality performance. Coordinate the initiation, review and approval of Contract Manufacturers and OEMs and finished goods product qualification plans with appropriate SMEs and stakeholders and provide guidance to ensure compliance with relevant SOPs. Manage and maintain supplier quality records up to date.

Experience

8-10 years of engineering experience and knowledge of the FDA Quality System Regulation, ISO
13485, and the Medical Device Regulation. 5+ years’ experience in IVD/ IVDR or medical device manufacturing or related industry Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR
820, ISO-13485, ISO-14971, ISO-9001

Specialized Knowledge

ISO 13485 leader auditor  Working knowledge of Medical Device Regulations, IVDR, CFR 820, ISO-13485,
ISO-14971,(Required). Risk management (FMEAs)  Validations and root cause analysis  Skilled in statistical methods. Experience in APQP, PPAP (Applicable Part/Process Qualification Methodology). Working knowledge of supplier quality management. Strong working knowledge of production and process controls in a regulated industry. Manufacturing engineering or manufacturing quality engineering experiences a plus. Sterilization Injection Molding Hardware manufacturing and automation Statistical Process Control  Measure System Analysis  Supplier Qualification (IQ, OQ, PQ) Root Cause Analysis (Fishbone, 8D, 5Whys & CAPA) Proficient in Project Management 

Education

BS or BA degree, preferred in one of the following: BioMedical Engineering, Chemical Engineering, Industrial Engineering, Quality Engineering. ASQ Supplier Quality Engineer Certificate a plus. Master’s degree a plus.

 

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $106,500 - $156,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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.

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

 

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