Senior Post Market Surveillance Specialist

Contract: until 31/1/26

Location: Remote

Pay: £153 per day

SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. Our client is seeking a Senior Post Market Surveillance Specialist to join their team. This position will have the objective of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements.

The Senior Post Market Quality Engineer is responsible and accountable for quality product surveillance deliverables required within the post market compliance & surveillance processes across Infusion Care business unit.

• Post Market Surveillance:

• Execute the Post Market Surveillance related processes.
• Establish and maintain Post Market Surveillance Plans and maintain update schedule.
• Facilitate and compile Post Market Surveillance (including PSUR) reports.
• Maintenance of product malfunction codes across Infusion Care business units.
• Participate in complaint escalation reviews.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Timely and accurate presentation of complaint analysis to all stakeholders.
• Support quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action.
• Execute and maintain procedures and processes to address post-market surveillance activities such as product investigations, periodic and ad hoc risk reviews, and product monitoring (trending and tracking) across all product franchises.
• Partner with team members (and cross-functional teams) to ensure the development and execution of streamlined robust solutions to post-market quality processes are effectively implemented.

• Develop understanding of the current risk profile for all products including reportable product harms and malfunctions.
• Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
• Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels.

• Adhere to all requirements of the Quality Management System.
• Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
• Continuously support Quality Master Systems Data update for Product Lifecycle, including but not limited to, New Product Introduction, Product Obsolescence, Heightened Product Surveillance and Manufacturing Site updates.

• Provide Post Market Surveillance Quality Input to Management Review slide decks as required.

• Support internal audits as required and act as an SME for the BU represented.
• Support external audits as required and act as an SME for the BU represented.

• Overall responsibility for ensuring technical rigor and compliance to applicable procedures during risk management, complaint, CAPA, and design related processes.
• Support R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance, external customers and equipment suppliers.
• The job holder will demonstrate the highest Quality standards, be able to impart knowledge and increase best practice across site/s and will embrace/drive core mission, values and priorities.
• Support continuous improvement of post market surveillance procedures, processes, and tools.
• Lead/manage microbiology laboratory related non-conformances, CAPA’s, planned deviations, change controls, OOS’s as required, ensuring corrective actions are fully implemented to address root causes etc.
• Perform other activities as and when required to support laboratory operations.

• Demonstrate company values, work with integrity, and be a supportive team member.
• Excellent written and verbal communication skills.
• Ability to navigate government regulations and standards, including Regulation (EU) 2017/745, 21 CFR 820, Part 203, ISO 13485 and ISO 14971.
• Experience with track wise, QMS.
• Safety reporting.
• Advanced MS Excel skills, including the ability to independently create and utilize pivot tables and charts, formulas, V-lookups, and other advanced data manipulation.
• Strong proficiency in Minitab.
• Ability to maintain composure and focus while managing multiple priorities, changing workloads, and meeting critical deadlines.

• Minimum of B.S., or equivalent experience, in a scientific/technical discipline is required.
• At least 5 years experience in quality role in a medical device or life sciences technology driven company.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Experience with various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization.
• Experience in product and process risk management.
• Experience in post-market surveillance activities (tracking and trending, investigations).