Supplier Quality Engineer 5 CR

• Education:

Minimum bachelor's degree in Microbiology / biomedical engineering / chemical engineering / biotechnology.

Master’s degree: desirable.

 

• Experience:

More than 10 years of experience as a professional in the same industry. Out of those years, 8 years of experience in the technical field required, sterilization.

 

• Specialized Knowledge: 

Knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820 (required).

ISO 13485 auditor certification (required).

EU Medical Device Regulation (MDR/IVDR) (required).

MDSAP (required).

Strong understanding of core tools (APQP, SPC, FMEA, etc.) (required).

Validations and root cause analysis (required).

 

• Languages ​​required for the position (Desirable): 

B2 / C1 English level (oral and written).

 

• Computer tools and knowledge level required (Desirable):

Strong computer skills, including Microsoft Word, Excel, Power Point; Visio; Project; Minitab.

 

• Qualifications: 

Strategic Agility.

Strong planning/ organizational skills.

Standing Alone.

Priority setting.

Customer Focus.

Conflict Management.

Process Management.

 

• Summary of Duties and Responsibilities:

Manages and ensures that all products and services purchased by Hologic to a Contract Manufacturer (CM), Original Equipment Manufacturer (OEM) and/or supplier, comply with the company’s defined specifications. This person will also be responsible for managing and ensure that the Quality Management system of the CM, OEM and/or suppliers are compliant with the applicable regulations where Hologic’s product is going to be commercialized.

Responsible for managing the investigation, analysis and resolution process for CM’s, OEM’s and/or supplier’s quality problems by conducting audits, analyzing defect trends, and leading continuous improvement projects.

Responsible to manage the follow up process on non-conformities raised during audits until objective evidence is gathered to demonstrate that CM’s, OEM’s and/or supplier’s CAPAs/SCAR's have been effective in eliminating previously observed non-conformances.

Works with CM’s, OEM’s and/or suppliers to ensure its performance is regularly reported and that appropriate and timely corrective actions are implemented. CM’s, OEM’s and/or supplier’s performance will be monitored by reviewing strategic KPIs established by Hologic.

Responsible to conduct and/or coordinate CM’s, OEM’s and/or supplier’s audits to enforce procedure and specification’s adherence to Hologic’s standards, as well as to foster continuous improvement.

Manages all CM’s, OEM’s and/or supplier related containment activities.

Reviews and approves root cause analysis and corrective/preventive actions to eliminate recurrence/potential occurrence of non-conformances related to Hologic’s product.

Works to resolve CM’s, OEM’s and/or supplier’s technical issues in a timely manner to ensure continuity of supply. 

Available to travel to CM’s, OEM’s and/or supplier’ sites if required on a frequent basis.

Establishes and maintains a quality agreement among CM’s, OEM’s and/or supplier’s & Hologic.

Approves all changes required by the CM’s, OEM’s and/or supplier’s that might impact Hologic’s product performance and/or specifications.

Support Hologic corporate tasks related to CM’s, OEM’s and/or supplier’s activities.

Strategically support CM’s, OEM’s and/or supplier’s performance improvement projects to increase CM’s, OEM’s and/or supplier’s capability of consistently meeting Hologic’s requirements.  Projects may include process analysis, value stream mapping, 6-Sigma, 5S, Kaizen events, etc.

Drives “Quality at the source “mentality within the CM, OEM and/or supplier.

Assures compliance with all applicable regulations where Hologic’s product is going to be commercialized.

Maintains close communication with the applicable Supplier Quality Divisional /Site Management to provide visibility and require support as needed associated to suppliers’ issues that need to be escalated in a timely manner.