Senior Post Market Surveillance Engineer

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Analyst - IT Infrastructure and you won’t either.

The Role:

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.

Complete execution of Post Market Surveillance plans and reports. This position is responsible for collecting, analyzing, and interpreting complex datasets to help guide the organization’s business decisions in scope of Post Market Surveillance activities. It works closely with business stakeholders to understand their needs, extract relevant data, and provide actionable insights through reports, dashboards, and presentations.

It plays a critical role in identifying trends, measuring performance, and suggesting optimizations to improve overall efficiency and strategy.  

Key Responsibilities:

• Execute the Post Market Surveillance related processes
• Establishes and maintains Post Market Surveillance Plans and maintains update schedule.
• Facilitates and compiles Post Market Surveillance (including PSUR) reports.
• Maintenance of product malfunction codes across Infusion Care business units.
• Participates 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.
• Partnering 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.

Design and Development:

• 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

Quality Management System:

• 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.

Management review:

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

Audit:

• 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.

Other responsibilities:

• 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 Convatec core mission, values and priorities
• Support continuous improvement of post market surveillance procedures, processes, and tools.

Authority (if applicable):

• Owns Records such as Document Control Changes, Non Conformances, CAPA, Complaint but not limited too
• Author, Approve, Review post Market Surveillance plans and reports

Skills & Experience:

Must Have:

• Demonstrate company values, work with integrity, and be a supportive team member.
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
• Ability to build and nurture strong and positive relationships with other leaders to partner effectively.
• Balanced technical understanding of products and processes combined with business and compliance acumen.
• Abitlity to navigate government regulations and standards, including Regulation (EU) 2017/745, 21 CFR 820, Part 203, ISO 13485 and ISO 14971.
• 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 and Power BI
• Ability to maintain composure and focus while managing multiple priorities, changing workloads, and meeting critical deadlines

Desirable:

• Six Sigma Green Belt/Black Belt certification or equivalent
• Statistical Analysis certification (preferred)

Qualifications/Education:

• Minimum of B.S., or equivalent experience, in a scientific/technical discipline is required.  
• At least 5 years experience in quality engineering 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)

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone. This is work that’ll move you.
 

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Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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