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

Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more.

Join us on our journey to #ForeverCaring as a Post Market Quality Engineer, and you’ll drive progress that really means something.

 

Position Overview:

The Post Market Quality Engineer is responsible and accountable for quality engineering deliverables required within the post market compliance & surveillance processes. Act as steward for post-market safety and quality, customer requirements/expectations, and regulatory compliance. Overall responsibility for ensuring technical rigor and compliance to applicable procedures during risk management, complaint, CAPA, and design related

processes. Serve as liaison between marketing, manufacturing, quality, and R&D to ensure post-market safety and performance are maintained for all product franchises.

Key Responsibilities:

Post Market and Complaint related activties:

Execute and maintain procedures and processes to support post-market surveillance activities such as product investigations, periodic and ad hoc risk reviews, and product monitoring (trending and tracking) across all product franchises.Execute 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.Acts as point of contact to execute Complaint analysis Activities across Convatec Business Units – Advanced Wound Care, Continence Care, Infusion Care, and Ostomy Care.Extract and generate Complaint performance data analysis necessary for generating applicable reports. Coordinate and provide oversight in the analysis of the complaint data.Support and Execute the Complaint return process as requiredOrganize and lead reviews with Development, Operations and Manufacturing on emerging quality issues and participate in any resulting corrective actions.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.Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity.Timely and accurate presentation of complaint analysis to all stakeholders, while concurrently supporting root cause analysis for any issues identified as required.

 

Design and Development:

Develop understanding of the current risk profile for all products including reportable product harms and malfunctionsProvide 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 and its KPIs.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.

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 quality engineering procedures, processes, and tools.

Authority (if applicable):

Act as the backup of the Complaint Manager and other peers in Post Market SurveillanceApprove quality Records in D2 Document Management system.Author, Review, Approve data analysis 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 leadership styleAbility 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, ISO 13485 and ISO 14971.Statistical Analysis certificationStrong project and time management skills, ability to work on multiple tasks concurrently with changing priorities.Proficient with of MS Word, Excel, PowerPoint, power BI and Minitab.

Desirable:

Certifications in Quality Management Systems (e.g. ISO 13485, 9001, lead auditor, ASQ, etc.)Six Sigma Green Belt/Black Belt certification or equivalent in statistics

Qualifications/Education:

Master’s degree in a technical or scientific field.  5+ years or equivalent experience in quality engineering role in a medical device or life sciences technology driven companyExperience 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, manufacturing processes within a medical device company and Experience in post-market surveillance activities (tracking and trending, investigations) 

Dimensions:

Team

N/A- No direct report

Principal Contacts & Purpose of Contact

Internal – R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance, Supplier, DistributionExternal – Customers, raw materials and component suppliers, contract manufacturers and equipment suppliers

Travel Requirements

Minimal travel, 5% travel required to domestic and international customers, design centers, manufacturing sites.  

Languages

Speaking:                  Yes                      EnglishWriting/Reading:    Yes                      English

Working Conditions

Appropriate EHS policies and procedures to be complied with relevant to the area.

Special Factors

Flexible working hours in accordance with CvT flexible working policy and as agreed with their manager

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.

This is a challenge more worthwhile.

This is work that’ll move you.

#LI-KM1

#LI-Remote

 

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.

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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!