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

 

Position Overview:

• Supporting Design & Development projects across the Advanced Wound Care Business Units, and other BU’s as required.

• Ensuring effective Design Transfer of new products into production.

• Ensuring compliance to FDA 21CFR Part 820, ISO 13485 and other applicable global Quality Management System regulations.

Key Responsibilities:

• Leads key areas for the development of new products within the New Product Development process. Responsible for ensuring that Design Control requirements meet regulatory and applicable procedural requirements.

• Works with the cross functional project leads to create and compile Design Control documentation as required to support regulatory compliance and submissions.

• Provides leadership as subject expert in Design Control and actively supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and in the execution of timely Design Reviews.

• Champions Risk Management activities through leadership, facilitation and active support during New Product Development, and post launch Change Control activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business, and product performance without compromising customer safety.

• Uses technical and cGxP knowledge to influence project planning and ensure quality and compliance from concept to launch.

• Provides input to post launch / lifecycle management activities.

• Works closely with manufacturing site teams to ensure a robust Design Transfer. Supports the development of comprehensive Quality Control Plans that meet the standards and requirements appropriate for the type of product.

• Participates in post launch reviews. Investigates product / process performance issues and participates in multifunctional evaluation of products in the market.

• Evaluates data using statistical tools.

• Where product Design Control or Risk Management is a factor, supports Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA).

• Supports product Change Control.

• Performs internal and supplier process audits as required to support New Product Development. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.

• Actively contributes to and, where appropriate, leads the improvement of Quality Systems such as Design Controls and Risk Management.

• Identifies and reports opportunities for improvement to peers and management.

• Identifies and fosters relationships with key suppliers, stakeholders, relevant networks and key opinion leaders.

• Liaises with other business functions such as Quality Management, Regulatory Affairs, Clinical/Medical Affairs, Sourcing, Operations and Marketing to ensure cross functional input during the execution of New Product Development.

• Takes responsibility for the measuring and monitoring of performance against agreed KPIs. Collates and shares information / data through reports and follows up on identified improvement opportunities.

Skills & Experience:

Required

• Experience gained within a Regulated Industry, preferable Medical Devices.

• Demonstrated knowledge of Design Controls, Regulatory and cGxP Compliance requirements such as QSR 21 CFR Part 820, EU MDR 2017-745, GMP Parts 210 and 211, and ISO 13485.

• Demonstrated knowledge and experience of Medical Device Risk Management ISO 14971 and the application and use of Risk. Management tools such as Hazard Analysis, FMEA and Process Mapping.

• Experience with Quality tools such as Quality Control Plans, Test Method Validation and Transfer, Root Cause Analysis, Process Validation, Process Optimization.

• Logical Thinking Skills and Experience: demonstrated ability to analyse and interpret complex problems / data gathered from a variety of sources.

• Demonstrated ability to effectively work and communicate in a cross-functional, multinational environment building co-operative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers.

• Practical experience of Notified Body audits and Regulatory Authority inspections.

• Good interpersonal skills and ability to influence people without direct authority.

• Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives.

• Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint.

Desirable

• Statistical knowledge and experience.
• Six Sigma knowledge, experience and certification.
• Experience of plastics, extrusion, injection molding, assembly, bonding.
• Statistical tools (e.g. Minitab) and MS Project and SAP knowledge.

Travel Requirements

• This position requires some Domestic and International travel to be undertaken, including overnight stays. Driving license required.

Languages

• Speaking:                        Yes                     English*

• Writing/Reading:          Yes                      English*

*additional languages as required or nice to have

Working Conditions

• This position is a mixture of office based and remote working with the office based at CTEC Deeside. The position may require auditing of suppliers, laboratories, and manufacturing facilities.  Applicable local workplace laws and statutes should be followed.

 

Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you’ll find them. Stretch your thinking, and you’ll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.

 

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 [email protected].

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!