Manager Quality for UK & Ireland
Quality Management is responsible for strategic oversight and leadership direction within the Quality function.
- Manage and improve a quality system in accordance to BDX guidelines and standards, and compliant with local governmental regulations on a national scale which apply to BDX country activities, business needs and internationally marketed products and services.
- Fulfils the role as BDX Quality Management Representative of the Quality system, ensuring that executive management is informed of Quality and customer issues or identified potential risks and that appropriate actions and resources are applied to quality and compliance concerns.
- Defines, implements and manages quality initiatives both internally and to end users.
- Provide direction for internal processes improvement, including sales, after sales, technical services and other applicable business activities and needs and support processes and assist Business Management for implementation.
- Duties / Accountibilities:
- Responsible for the following; Quality Assurance, internal auditing, CAPA, customer complaints management, documentation control, quality control, suppliers evaluation and auditing
- Responsible for the maintenance, improvement and assessment of the effectiveness of the quality management system, in accordance with BDX standards and compliant with all applicable (inter)national regulations.
- Plan, direct and control all quality activities supporting the introduction of new products, and the modification of existing products on the UK and Irish market. This activity does not include ownership of products (while owned by the business unit), but is supporting the commercial organization in a country from Quality perspective, as Quality business partner
- Maintain awareness of new and developing regulatory trends and requirements, to decide on follow-up for Quality management and QMS
- Work with internal staff (country and business management), external suppliers and BDX employees to ensure quality processes meet regulatory and company guidelines.
- Act as primary contact for certification bodies
- Measure and evaluate the effectiveness of Quality management system.
- Coordinate field corrective actions (recall, hold, advisory notice) as per Business Units and legal requirements, in cooperation with Regulatory Affairs. Quality is coordinating the customer communication. Execution of this communication may vary per country and per BD entity.
- Provide training in company quality policies and procedures to ensure the Quality Management System is understood and followed and quality awareness is promoted.
- Provide quality support to the sales and marketing team (for example for tenders & offers).
- Review the translation of quality deliverables as required (for example per CFN BCCR- Business Claims and Communications Approval process).
- Manage Customer complaints reporting system providing analysis, investigation, reports and feedback to executive management, customers and authorities, in conjunction with RA, as required, from a customer, country and business perspective.
Desired Competencies & skills
- Team player and ability to work to deadlines
- Strong external customer focus and internal influencing and networking skills
- Positive and professional attitude with a positive disposition
- Excellent organizational skills and ability to lead projects involving multgi disciplinary teams
- Flexible & adaptable with capability and willingness to embrace change
- Experience and ability to function in a matrix organisation
- A university degree in an engineering or life science discipline.
- Well familiar with European regulations on Medical Devices (MDD 93/42), and the specific European guidelines (MEDDEV) and with the specific UK & Ireland regulations, as well as with quality system standards ISO 13485 and/or ISO 9001.
- Minimum 5 years of experience in senior quality roles in medical device industry.
- Excellent communication and interpersonal skills, and the capability to work on own initiative and as a team member.
- Good written and oral communication in English.
- Computer skills including Microsoft Word, PowerPoint and Excel.
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