Design Assurance Quality Director

Convatec; Greater London; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Design Assurance Quality Director to lead a dedicated team in ensuring the highest quality standards for innovative medical products. This role involves overseeing product development processes, implementing quality management systems, and driving continuous improvement initiatives. The ideal candidate will possess extensive experience in medical device regulations and quality assurance, coupled with strong leadership skills. Join this forward-thinking organization and contribute to enhancing patient outcomes through cutting-edge solutions. If you are passionate about quality and innovation, this is the opportunity for you.

Qualifications

• Experience in Quality Systems for medical devices and pharmaceuticals.
• Ability to lead teams and manage complex quality projects.

Responsibilities

• Lead Quality Assurance team supporting new product development.
• Ensure compliance with regulatory standards and quality policies.

Skills

Quality Management Systems

Design Controls

Risk Management

Statistical Data Analysis

Medical Device Regulations

Education

Bachelor's in Scientific/Technical Discipline

Advanced Degree (M.S., M.B.A, Ph.D.)

Tools

Quality Management Software

Statistical Analysis Tools

Job description

Convatec Paddington, England, United Kingdom

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Convatec Paddington, England, United Kingdom

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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. 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

At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as our Design Assurance Quality Director, and you’ll do the same.

In this role, you will be responsible for leading the Quality Design Assurance Team supporting new product development for ConvaTec. You will be the primary quality contact for the Technology and Innovation (T&I) group to support product launches and ongoing design changes.

Your Key Responsibilities:

• Lead, mentor, coach, and develop team of technical Quality Assurance professionals who collaborate with T&I on the design, development, and manufacturing transfer of new or changed medical device products.
• Ensure appropriate application of company policies and procedures for product development, risk management, test method development, statistical data analysis, and support of regulatory filings.
• Lead the continuous improvement of the quality system elements that support the design, development, and manufacturing transfer of new products.
• Maintain oversight of cGMP documentation, including, but not limited to product development reports, change control, validations, methods, and technology transfer.
• Ensure documents are thorough, accurate and compliant to support regulatory inspections and submissions.
• Provide support for investigations and recommend, develop and implement effective corrective actions.
• Provides support during regulatory inspections and customer audits.
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
• Proactively investigates, identifies and implements improved quality practices.
• Ensure operations within approved department budget.
• Responsible for personnel actions including hiring, performance management, and termination.
• Ensures compliance in compiling and maintenance of Design History Files.
• Drives a consistent approach to Design Controls across all the business units in ConvaTec.
• Define and manage KPIs for related Quality Management Systems, in partnership with T&I
• Ensures timely investigations and implementation of corrective actions related to design.
• Permanent quality member for stage gate reviews/approvals.
• Part of the T&I extended leadership team.
• Part of the GDC site leadership team, including quality oversight of test laboratories that execute design validation, verification, and stability studies.
• Management representative for GDC.
• Ensures that QMS requirements are effectively established, implemented, maintained, and documented in accordance with standards and regulations identified in the reference section of the quality manual.
• Reporting to management on the effectiveness of the quality management system and any needs for improvement.
• Ensuring the promotion of awareness of the applicable regulatory and QMS requirements throughout the organization.
• Ensuring quality policy is understood, implemented, and maintained at all levels of convatec.
• Have oversight and support quality activities at the convatec Canada Ltd site as well as the Boston development site, ensuring compliance on the execution of the processes.
• Lead 3rd party due diligence related to design quality/design controls.
• Lead, direct, or execute vendor approval audits related to new product introductions.
• Direct a team of design assurance and quality system managers with direct assignments to each business unit, ensuring close partnership with T&I on the development & launch of new products. This team covers design activities at all locations across convatec, and includes software as a medical device.
• Has a total of minimum 7 direct reports, including global process owners for critical technical functions that impact all of convatec (risk management and statistical techniques).
  
  
  

Your key contacts :

Internally :

Global quality management, T&I, M&A, Legal, Regulatory Affairs, Clinical Affairs, Quality Engineering, and all other functions as required by the role

Externally :

Regulatory Authorities and Notified Bodies

What we are looking for in you :

• Breadth of professional field and industry knowledge.
• Experience working in Quality Systems/Processes that cover Medical Device Design Controls and Pharmaceutical Development preferred.
• Ability to integrate critical information and champion advanced strategies/concepts through the organization.
• Drives development of advanced technologies, principles and processes.
• Ensures budgets, schedules, and performance requirements are met.
• Judgement is required in resolving complex problems based on experience.
• The ability to work in a cross functional team and ensure compliant project execution is a must.
• Deep understanding of Design Controls and Design Change Process
• Experience working in international environment in a global position is preferred
• Minimum of B.S., or equivalent, in a scientific/technical discipline is required. Advanced degree (M.S., M.B.A, Ph.D. or equivalent) preferred.
• Certifications in Quality Management Systems preferred.
• Ten+ (10+) years in the medical device and/or pharmaceutical industry.
• Five to seven (5-7) years experience in a leadership role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Written and spoken English. Another language would be an advantage
  
  
  

Key competencies :

• Ability to think in clear, decisive manner, remaining calm under stressful and challenging conditions.
• Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
• Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
• Understanding of risk management principles and ability to apply these principles in day to day quality management activities, compliance issues, and business challenges.
• Commercially astute and customer focused.
  
  
  

The role will require c25% travel

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 [e-mail].

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

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing

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