Process Validation Leader

Our client is a renowned international player in the production, advisory services, and sales of specialized medical products, with a portfolio across cardiovascular, ophthalmic, microsurgery, plastic, orthopedic, dental & maxillofacial surgery, and other surgical specialties.

It is a proudly Mexican company with more than 56 years of history, built on strong values of ethics, excellence, innovation, and commitment to healthcare.

They manufacture high-quality surgical sutures and medical devices, contributing to the care of millions of patients in Mexico and in more than 80 countries worldwide. With over 900 employees, they have been the leading supplier of surgical sutures to the Mexican Public Health Sector for more than 30 years and are ranked among the top ten companies globally in our segment.

This role will assume technical, production, and quality ownership of the semi-finished barbed suture project—from start to finish, from process development and validation (IQ/OQ/PQ) through transfer to operations—to meet the project’s committed timelines and objectives. The position combines hands-on technical execution on the production floor (equipment qualification, drying and packaging of absorbable material, process industrialization) with the project leadership discipline (schedule, budget, risks, and technical decisions) required to maintain the pace committed to IFSA.

The position reports directly to Atramat Santec’s Operations Management and, together with the Quality System & MDR Certification Coordinator, represents the second key element of the 2026–2027 plan: while the latter provides management structure and execution discipline, this role provides technical execution capability.

Position design principle: The profile should be selected based on a product engineering foundation, not solely on equipment qualification experience, because upon completion of the barbed suture transfer (Q3 2027), the role will evolve toward product development—particularly the ePTFE suture project. This criterion is part of the evaluation and is not merely a desirable qualification.

Key Responsibilities

1. Technical and project leadership of the semi-finished barbed suture project: schedule, budget, and resource allocation, with direct and periodic reporting to Operations Management.
2. IQ/OQ/PQ validation packages for the semi-finished process (barbing, drying, and packaging): protocol, execution, deviations, and report; no report without a prior plan.
3. Commissioning and optimization of the existing barbing machine and development of the drying and packaging stages with the Production Manager. Absorbable material is moisture-sensitive: drying and barrier packaging are critical process steps, not finishing operations.
4. Capability studies, sampling plans, and acceptance criteria aligned with the specification agreed upon with IFSA.
5. Design reviews, risk management, and technical decisions for the project, in coordination with Quality Management.
6. Process documentation: work instructions, process parameters, in-process controls, and production records; ensures that the project is executed in accordance with Santec’s Quality Management System (QMS).
7. Pending validations within the current product portfolio, prioritized in coordination with Quality Management.
8. Transfer to operations: 7.3.8 package with defined exit criteria, production training, and support during the production ramp-up.
9. Tracking project performance in terms of schedule, cost, quality, and productivity, as well as coordination with equipment and material suppliers.
   
   

First 6-Month Deliverables

• Approved project plan (schedule, budget, and resources) for the barbed suture project, approved by Operations Management (November 2026).
• Barbing machine validation completed and drying and packaging equipment qualified — IQ/OQ packages closed (April 2027).
• Approved PQ plan for the complete process, including acceptance criteria and sampling plan.
• At least one pending validation from the current portfolio closed as a complete plan + report package.
  
  

Requirements

• Education: Mechanical, biomedical, materials, or polymer engineering.
• Experience: 3–6 years in medical device manufacturing or polymer processing, with demonstrated experience leading or coordinating projects (schedule, budget, multidisciplinary teams), in addition to process validation (IQ/OQ/PQ) experience involving validation packages the candidate has written.
• Applied statistics: Process capability, sampling, and validation data analysis.
• Preferred: Extrusion, spinning, or suture manufacturing; experience with absorbable or moisture-sensitive materials (drying, barrier packaging); cleanroom experience.
• Languages: Strong German or English (B2+). Validation documentation is produced in English; sufficient fluency is required to coordinate with the team, suppliers, and headquarters (IFSA).
  
  

Competencies and Selection Criteria

Strong documentation discipline (planning before execution), hands-on presence on the production floor, and autonomy, combined with the ability to keep a project on schedule, within budget, and at the required quality level without needing to be reminded.

During the interview, ask candidates to provide an example of a validation package they have written from scratch and ask what they would do if an OQ fails an acceptance criterion—the correct response is a documented deviation and re-planning, not a silent adjustment.

Also ask for an example of a technical project they led from start to finish, including their own schedule and budget, and how they managed a risk that threatened the delivery date.

Explicitly assess their product design/development foundation (prototypes, design inputs, testing) given the planned evolution of the role toward ePTFE development.

Natural Career Progression

Upon completion of the barbed suture transfer (Q3 2027), the position will evolve toward product development, particularly the ePTFE suture project, or toward a technical project leadership role within Operations Management.