At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Primary Function of Position:
The Senior Manager Product Quality will lead the Quality Operations and Quality Engineering team for Intuitive’s manufacturing facility in Parvomay, Bulgaria.
Primary functional responsibilities include leading the team of Quality Engineers as well as the Quality Operations team including Incoming Quality Control (IQC), Material Review Board (MRB), Preventive Maintenance and Calibration (PMC), Final Quality Inspection (FQI) and Product Release (DHR). This key management role will be challenged to effectively lead the quality resources required to support business growth sales demand through the successful introduction of new products, process, and facilities. The Quality Manager will directly support all audit related activities both internal and external for the Parvomay facility. This role will work directly with plant leadership to align on goals and objectives and will ensure maintenance and further development of the quality management system. The Quality Manager will lead continuous improvement activities within the Quality Operations and the Quality Engineering team.
Roles and Responsibilities:
- Ensuring compliance with legal, normative and internal requirements in connection with the products and processes in the company
- Active participation in the strategic development of the team
- Technical and disciplinary management of the team
- Coaching and qualification of the employees in the team
- Assure all operations are performed in accordance to procedures
- Perform periodic audits to verify correct and consistent operations
- Determine, maintain Product Quality CIP/department goals
- Track recurring issues and escalate as needed to achieve root cause corrective action
- Interface on a daily basis with internal customers to provide status of open issues and drive those items to closure
- Drive cross-functional issue resolution
- Facilitate interdepartmental resource allocation
- Preparation and implementation of the management review and the associated documentation of quality-related topics
- Handle materials in accordance to procedures, and maintain traceability of component materials as to inspection status
- Proactively recognize environmental changes and provide coordinated direction for mitigation
- Overall planning and execution of internal and external audits and initiation of corrective and improvement measures per the audit outcomes
- Drive improvements in safety, production, quality, cost, and delivery
- Allocate resources appropriately to achieve departmental objectives
- Develop leadership personnel within the department in order to support growth
- Write and conduct formal annual performance reviews for staff
- Develop and manage departmental budget
Required Knowledge, Skills, and Experience:
- BS degree and 8 years of management experience, minimum 4 years as Quality Manager preferably in Quality Operations or Quality Engineering.
- Outstanding management and communication skills. Experience in leading technical teams.
- Experience in Medical Device industry.
- Knowledge of RE-Manufacturing processes desirable.
- Knowledge of returned material decontamination processes desirable.
- Must be computer literate with experience using Windows, Excel, Word, PowerPoint.
- Previous manufacturing experience with SAP and/or document control systems a plus
- Relevant professional experiences and working knowledge in medical device Quality Management System and standards such as ISO 13485 (or ISO 9001) and ISO 14971. Understanding of CFR 21 820, MDSAP and MDR.
- Must be familiar with all standard inspection tools, gauges, optical comparators and various types of coordinate measuring machines effectively.
- Good understanding of Inspection (GD&T), Metrology, PMC, and GMP (Good Manufacturing Practices).
- Must have a working knowledge of MRB related activities.
- Working knowledge of quality tools and quality data analysis e.g. measurement repeatability systems, process control tools (Statistical Process Control), DMAIC process, 5 Why's, control charts, and fishbone diagram.
- Working knowledge of Lean / Six Sigma.
- Excellent creative problem-solving skills.
- Good interpersonal skills.
- Excellent communication and documentation skills in English and local language.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.