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Quality Assurance Supervisor
3 months ago
Position Title: Quality Assurance Supervisor
As a pivotal member of our team, you will:
- Oversee and guide a team of Quality Assurance professionals.
- Deliver leadership in managing investigations, deviations, change controls, validation processes, standard operating procedures (SOPs), and in-process quality controls.
- Foster collaborative partnerships between Operations and Quality to enhance the overall customer experience.
- Support Operations in diagnosing and resolving quality and process-related challenges.
- Collaborate with Operations, Research & Development, Procurement, and Engineering to elevate quality standards and minimize costs.
- Concentrate on enhancing efficiency and compliance within the quality management framework.
- Work alongside Operations to set up controls and inspection points for nonconforming materials, components, assemblies, and finished products.
- Act as the Quality Representative for all corrective and preventive actions related to quality.
- Ensure adherence to company policies, as well as national and international regulations and safety standards.
- Examine trends, perform root cause analyses, and implement corrective measures for processes and products.
Essential Qualifications:
- Bachelor's degree in a scientific discipline or a related field.
- Demonstrated experience in a regulated sector, preferably in quality assurance within the medical device or pharmaceutical industries.
- Experience in managing and nurturing a team within a quality-focused environment.
- Strong foundation in process control and statistical methodologies.
- Familiarity with medical device regulations, current Good Manufacturing Practices (cGMP), European Union regulations, or ISO 13485 standards.
- Exceptional interpersonal communication skills, both verbal and written.
- Self-motivated with the capability to achieve results from broad concepts and guidance.
- Ability to manage multiple priorities in a global, multi-site organization.
- Effective collaboration within cross-functional teams.
- Proficiency in quality management tools such as Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), Design of Experiments (DOE), and Six Sigma/Process Improvement methodologies.
- Strong digital proficiency, including experience with SAP, Microsoft Word, Excel, and PowerPoint.
- Expertise in qualification and validation processes (including sterilization, cleaning, and software validation).
Key Competencies:
- Outstanding interpersonal abilities.
- Strong leadership and influence skills.
- Capability to work autonomously as well as collaboratively.
- Robust quality assurance background and decision-making capabilities.
- Aptitude for addressing complex issues while aligning with regulatory requirements.
- Commitment to continuous improvement initiatives.