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- Tasks: Lead post-market surveillance to ensure product quality and compliance in medical devices.
- Company: Join Convatec, a global leader in medical solutions improving lives across 100 countries.
- Benefits: Enjoy a supportive work culture with opportunities for growth and minimal travel requirements.
- Why this job: Make a real impact on patient safety while working with innovative technologies in healthcare.
- Qualifications: Requires a degree in a scientific field and 5 years of quality engineering experience.
- Other info: Be part of a team that values integrity, collaboration, and continuous improvement.
The predicted salary is between 30000 - 42000 £ per year.
Senior Post Market Surveillance Specialist
Senior Post Market Surveillance Specialist
3 days ago Be among the first 25 applicants
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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. Group revenues in 2022 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
We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right.
Position Overview:
- 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.
Duties And Responsibilities
Post Market Surveillance:
- 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.
Market Action:
- Execute the Market Action process end to end according to procedure for Corporate
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:
- 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
- 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)
Travel Requirements
- Minimal travel, less than 5% within Europe but overseas travel is expected.
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.
#LI-Onsite
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.
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.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View \”Convatec Internal Career Site – Find Jobs\”. Thank you!
Seniority level
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Seniority level
Mid-Senior level
Employment type
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Employment type
Full-time
Job function
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Job function
Sales and Business Development
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Industries
Medical Equipment Manufacturing
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Senior Post Market Surveillance Specialist employer: Convatec
Contact Detail:
Convatec Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Post Market Surveillance Specialist
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as Regulation (EU) 2017/745 and ISO 13485. Understanding these will not only help you in interviews but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in post-market surveillance. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss your experience with data analysis tools like Minitab and advanced Excel functions during the interview. Being able to showcase your technical skills in handling complex datasets will set you apart from other candidates.
✨Tip Number 4
Research Convatec’s core values and think of examples from your past work that align with them. Showing how you embody their values like 'Improve Care' and 'Do What’s Right' can make a strong impression during your interview.
We think you need these skills to ace Senior Post Market Surveillance Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality engineering, particularly in the medical device sector. Emphasise your familiarity with regulations like ISO 13485 and your ability to analyse complex datasets.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving patient outcomes and your commitment to quality standards. Mention specific examples of how you've contributed to post-market surveillance or quality compliance in previous roles.
Showcase Your Skills: Highlight your advanced skills in MS Excel and Minitab, as well as any certifications like Six Sigma. Provide examples of how you've used these skills to drive improvements in quality processes.
Research Convatec: Familiarise yourself with Convatec's core values and mission. Reflect on how your personal values align with theirs and be prepared to discuss this in your application and potential interviews.
How to prepare for a job interview at Convatec
✨Understand the Regulatory Landscape
Familiarise yourself with key regulations such as Regulation (EU) 2017/745 and ISO standards relevant to medical devices. Being able to discuss these regulations confidently will demonstrate your technical knowledge and commitment to compliance.
✨Showcase Your Data Analysis Skills
Prepare to discuss your experience with data analysis tools like MS Excel and Minitab. Be ready to provide examples of how you've used these skills to interpret complex datasets and drive business decisions in previous roles.
✨Emphasise Team Collaboration
Convatec values teamwork, so be prepared to share examples of how you've successfully collaborated with cross-functional teams. Highlight your ability to build strong relationships and work towards common goals.
✨Demonstrate a Commitment to Quality
Discuss your approach to maintaining high quality standards and patient safety. Share specific instances where you identified trends or issues in post-market surveillance and how you addressed them to improve product quality.
