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Senior QA Manager EMEA

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Senior QA Manager EMEA

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Limburg Netherlands.

A pioneering interventional and diagnostic technology company with a portfolio of advanced products. We are also a global market leader in advanced contrast imaging systems for cardiovascular angiography.

ROLE DESCRIPTION

Conducts overall leadership of the full QA function as part of the organization. Ensures EU site processes for QMS & Audit, Operational Quality, Product Quality, Post Market Surveillance & Vigilance and Quality Training & Education comply with Corporate and Regulatory requirements.
Leads a team of 6 team members of the QA team EU and is a member of the Management Team (MT) together with EU team leaders of Sales & Marketing (direct and indirect markets), Finance, Service & Logistics and Human Resources.

Hierarchical position
Receives hierarchical and functional guidance from the Global Senior Quality System Manager and from the Senior Director QMS & Supplier/Product Quality, both based at, U.S.A.

RESPONSIBILITIES

General
- Monitor and manage the overall QA organization including all disciplines, objectives and results.
- Provides cross-functional leadership, oversight, direction, decision making and communication necessary to ensure that the Quality System complies with all relevant EU Directives, ISO13485, Corporate, Legal and business requirements.
- Interacts routinely with EP Global Senior Quality System Management.
- Interacts frequently with internal and external partners including but not limited to field staff, distributors, 3rd party service providers, BINJ, Notified Bodies, CA’s, XIP companies
- May interact with customers as necessary.
- Responsible for the annual QA budget for QA E.M.E.A.
- As a member of the European MT team and MTO team responsible to manage and control company’s objectives and overall EU operation.

Result: objectives around full compliance with corporate objectives including Quality-, New Product Introductions and enhance Organizational Capabilities are met.

(People) leadership and employee development
- Direct and coordinate the day to day activities and projects of a team of professionals responsible for product quality in EMEA.
- Recruit, select and retain a high performance team.
- Assign and monitor staff objectives and workloads.
- Promote employee development and foster growth of employees through:
- Performance Management
- Skills development
- Continuous one-on-one feedback
- Bi-annual appraisal of individual performance
- Recognition and motivational techniques/tools to drive high levels of employee performance and engagement
- Coaching and mentoring of staff
- Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes.
- Establish clear SMART goals and objectives by which to determine individual and/or team results.
- Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals.
- Provide communication forum for the exchange of ideas and information with the department. Ask questions; encourage input from team members.

Result: team is sourced well and people are coached and managed in line with leadership expectations.

Quality System, Audit, CAPA, TRAINING:
- Manage the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Utilize quality system processes to support corporate objectives and continually improve the effectiveness of the quality system in Europe.
- Overall management of Quality Management System in E.M.E.A. territory
- Overall management of CAPA process and ensure effective globalization in collaboration with corporate quality management
- Ensure that preventive actions and other quality system improvements are being taken and are documented within the CAPA system as required.
- Overall management of all quality systems audit programs and audit plans including external audits, internal audits, distributor assessments and 3rd party audits
- Ensure applicable and required quality related training courses are conducted and completed

Result: ensure good management practices with QMS staff and reach full compliance with all quality requirements and quality objectives.

Postmarket Surveillance & Vigilance:
- Supports the preparation of MDRs, Vigilance Reports, EU Problem Reports and other Adverse Event reports and act as contact person with the authorized representative for CVI.
- Communicate with internal staff, field staff and EMEA partners and global partners as required to support complaint activities.
- Maintain complaint handling procedures in accordance with the EU quality system regulation, ISO 13485 and the applicable regulatory requirements and Corporate Quality System.
- Monitor complaints for adverse trends and report as necessary.
- Generate and oversee analysis, trending and reporting of complaint data for monthly reports, complaint meetings, management reviews and in response to internal requests.
- Provide in collaboration with PMS team quality and complaint related.
- Participate in monthly cross functional complaint review meetings; including Customer Services, Technical Services and Logistics.
- Monitor and maintain corporate awareness of new regulatory and statutory requirements regarding the company’s compliance activities.

Result: compliance with current and future PMS requirements as part of Product Life Cycle requirements according to current EU MDD and future EU MDR regulations.

Operational Quality
Manage the Europe Operations Quality team member(s) related to technical service operations, logistics, warehousing, distributions including Receiving Inspections, Incoming Inspections, Non-conforming Product Handling, Returned Product Handling, and Supplier Quality. All in compliance with relevant standards and regulations as well as the Corporate Quality System.
In addition ensure bi-directional management/communications by and between EU Operational Quality- and Global Operational Quality functions.

Result: comply with corporate operational quality targets.

Product Quality Assurance
Manage the Product Quality Engineer team member(s) and provides all necessary management support, input and control from a product quality-, product performance- and product complaint perspective for all devices falling under the scope and responsibility of Europe for Operations, field staff, distributors and other 3rd party organizations. In addition ensure bi-directional management/communications by and between EU Product Quality- and Global Product Quality functions.

Result: comply with corporate product quality guidelines and targets.

Other:
- Responsible for managing QA driven projects and participates in other (cross functional) projects as outlined in applicable EU Project Funnel Overview including applicable QA Project Master Record.
- Assist with product recall activities.
- Control of field support documents such as field/customer instructions, technical information books, adverse event forms, complaint forms or any other PMS related document.
- Member of the EHS team, ISO plant management Representative and EU Authorized Representative for HDi and RXi.

REQUIREMENTS

Required Experience
- Degree (Master/Bachelor) in Engineering and/or Science or equivalent experience.
- Minimum 5 years of Quality and PMS experience in international medical device industry, preferably with electromechanical devices.
- Strong knowledge of medical device regulations, standards, guidelines.
- Working knowledge of MD distribution, business operations, quality systems, process improvement tools, PMS processes, manufacturing and product life cycle and risk management.
- Excellence in communications and high level diplomacy within company’s organization, external parties and competent authorities.
- Ability to execute day-to-day leadership on senior level as part of global leadership; achieve results through influence and problem solving skills.
- 5 years of management or supervisory experience.
- Demonstrated (people) leadership skills.
- Strong language skills in Dutch, English.
- Strong knowledge and experience with ISO 13485 quality system requirements, EU MDD regulations and local regulations within EU member states.
- Ability to develop clear, concise, and timely oral and written reports.
- Ability to professionally communicate and work across cultures, geographies and global business partners.
- Experience working with a centralized corporate office and within a Global Management environment.
- Demonstrated project management skills in order to plan, conduct and implement system assessments.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Minimum 5+ years’ experience in working with US medical device companies.
- Critical thinking, root cause analysis and problem solving skills including risk management.
- Good tactical skills to manage top-down as well as bottom-up.
- Ability to travel internationally.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.

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