SENIOR MANAGER, QA ENGINEERING
BRIEF COMPANY PROFILE
Our client is a global leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. The company’s advanced solutions and products help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal care and wound care.
The company is located in Greater Copenhagen.
Reporting to the Director of QA Engineering – the Senior Manager, QA Engineering, will take a seat on the Global QA Engineering leadership board while leading a team of 8 FTE’s with focus on ensuring reliable and compliant product development and the maintenance of existing product platforms. There are currently plans to expand the team with two additional employees.
The team will support all design control aspects within designated core products.
The ideal profile for the position is an experienced Design Control specialist and leader. The role will be responsible for representing Quality Assurance in design and development projects collaborating closely with R&D, Operations and RA – alongside other QA teams at HQ and among subsidiaries to assure high quality alignment throughout the development process, including design transfer.
Additionally, the role will be responsible for assessing overall product design risk by facilitating the development of risk management tools and contributing to the completion of the overall product risk management evaluations. As the role on occasion is expected to take on specialist tasks, the ability to document test data, analyze test results, utilize statistics, write clear and concise reports, and to make recommendations to evaluate products, is required.
Senior Manager, QA Engineering
Director, QA Engineering
20-30 days per year
Responsibilities & Tasks:
Global responsibility for our clients QA Design Control platform within key products.
Team Leadership – creating a high performing team
Managing, training and developing the team and their personal and professional competencies.
Setting a clear direction and priorities for the team.
Ensuring appropriate performance objective planning, reviews, talent assessment, hiring, budgeting and planning for the department.
Ensuring continuous resource allocation and planning within the department and with relevant external partners, and thus ensuring effective and timely handling of services as committed.
Making sure the team works in alignment with others e.g. R&D, RA and Operations – alongside other QA teams at HQ and among subsidiaries.
Mobilizing the potential of every employee.
Providing guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
Participating in quality training activities.
Keeping updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
Contributing to improving best practice sharing across QA departments at HQ and among subsidiaries.
Representing Quality Assurance in design and development projects and on cross-functional teams supporting new product development.
Collaborating closely with R&D, Operations and RA – alongside other QA teams at HQ and among subsidiaries to assure high quality alignment throughout the development process, including design transfer.
Quarterly perform detailed planning of project deliveries and commit to supporting projects as resources allow.
Assessing overall product design risk by facilitating the development of risk management tools and contributing to the risk management evaluations.
Key success criteria:
Ensuring improved alignment and matching of expectations between the QA Design Control team and key stakeholders such as e.g. R&D, RA and Operations – alongside other QA teams at HQ and among subsidiaries.
Leveraging the extensive QA Design Control capabilities within the team while providing compelling leadership of the team.
Ensuring appropriate prioritization of tasks within the team.
Successfully driving a high-performance culture focused on adding value in alignment with the business and talent management – eventually delivering strong engagement survey outcome.
Achieving operational excellence within the Design Control area by ensuring that the right capabilities, structures, systems and processes are in place.
Preferably degree at B.Sc. or M.Sc.-level in Engineering or similar e.g. within chemistry, electronics, software or mechanics.
English – fluent verbally and in writing.
Ideal experience and competencies:
Preferably prior management experience.
QA Design Control experience from the medical device or IVD industry.
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and MDD).
Knowledge/experience with Risk Management.
Experience with navigating in a global/large organization.
Demonstrated superior understanding of the business and how own area integrates with others to achieve departmental objectives.
Well-versed in adapting departmental plans and priorities to address resource and operational challenges.
Preferably proven track record with problem solving and continuous improvements.
Good working knowledge of IT tools and specifically Quality Management systems.
Works systematically; organizes work and effort; is methodical in one's performance; holds on to commenced tasks and projects with skills for planning and visual management.
Assesses the importance of considerations, decisions and actions, analyses the most important issues first.
Is able to pull decisions through and withstand or overcome adverse conditions. Encourages the achievement of set goals by promoting a sense of purpose by demonstrating strong drive, stamina, natural authority, and responsibility. Prompts a strong wish to succeed within the team and with each individual.
Is proactive and able to inspire others and is able to take own initiatives without hesitation. Actively seeks influence and starts up actions on own initiative.
Seeks to give individual and personal service to stakeholders and follow up on the service provided seeks new ways of improving the service in realistic and efficient ways, values stakeholders/customers and service highly.
Delegation and coordination
Delegates responsibility to the relevant employees and allows them room for maneuver to explore own initiatives, empowers people in order for them to carry out tasks efficiently.
Results and goal orientation
Is result-oriented, driven, persistent and motivated by strengthening team input to ensure strong organizational output. Establishes visible and achievable, yet ambitious, goals. Focuses on action, activities and results.
Excellent cross-cultural communication and presentation skills. Is to the point and communicates the central issues in a discussion in a clear, fluent and precise manner. Is able to keep the recipients' attention, attentive to the needs of others when he/she speaks. Produces clear/precise/fluent/understandable written material.