Sr Supervisor, Quality Systems

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 

How you’ll make an impact:

• Supervise the Documentation Center team and oversee the daily activities, including establishing schedules, prioritizing work based on organizational and business need, coordinating the execution of document change and archiving activities, ensuring staff is appropriately trained to perform assigned work, and provide guidance and coaching.

• Serve as the primary liaison between Regulatory Affairs and site functions, leading coordination of regulatory impact assessments associated with changes, projects, and business initiatives. Collaborate with corporate and cross-functional teams to ensure regulatory requirements are evaluated, communicated, and incorporated into documentation and quality system processes.

• Maintain expertise in Quality Systems requirements and processes to provide compliance-focused guidance and decision support to the Documentation Center and cross-functional stakeholders and actively participate in the internal audit program to promote system effectiveness and regulatory compliance.

• Lead in the evaluation of current and new processes, the identification of opportunities and the implementation of solutions to improve the efficiency of processes within and between related functional areas. Identify technical and/or process problems to determine the root cause, propose recommendations and develop improvement strategies to fill the skills/competence gaps.

• Ensure compliance with internal procedures, and implemented change control process continuously meet EW Quality System in compliance with regulatory requirements.

• Review and analyze metrics associated with document change activities, records management, and archiving operations, including processing times, aging, backlog, rejection trends, and storage capacity, and provide performance insights and recommendations to management.

• Other incidental duties assigned by Leadership.

What you’ll need:

• Bachelor's Degree in related field (e.g., industrial, chemical, electrical, mechanical, business administration). Required

• More than 5 years of experience leading teams in quality areas, working with cross-functional teams, substantial technical knowledge, and experience in related manufacturing, quality and/or product development engineering. Required

• Knowledge in quality systems related to CAPAs (corrective and preventive action) and NCRs (non-conformance report).

• Experience working in manufacturing process, medical device industry or related industries (electronics, pharmaceutical, food industry or related). Preferred

• Advance English level. Required

Work shift:

• Availability to work from Monday to Friday from 8.00 a.m. to 05.00 p.m.

What else we look for (preferred):

• Proven project management expertise

• Proven expertise in both Microsoft Office Suite, Enterprise Resource Planning (ERP) system, preferably JDE

• Excellent written and verbal communication, and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, as well as mediating and negotiating the needs of other areas to achieve consensus

• Solid understanding of medical device documentation development activities

• Full understanding of quality procedures while applying acquired expertise to analyze and solve problems without clear precedent

• Demonstrated ability to supervise teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee of employee

• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

• Ability to interact professionally with all organizational levels

• Must be able to work with cross-functional teams as well as with colleagues from other departments within assigned area

• Complete understanding and wide application of principles, theories, and concepts in business area

• Ability to develop creative solutions to challenging problems; adept and experienced problem solver who is capable to determine root cause of technical issues and implements effective solutions in a timely manner