Work Flexibility: Onsite
Excel with us as a Senior Quality Manager!
PositionSummary
Establish a quality centre of excellence, develop organisational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. Oversee the consistency of quality processes. Manage and address potential product and safety investigations through investigation and corrective action.
What You'll Do:
1. Manage day-to-day quality processes to ensure issues are appropriately evaluated
2. Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate managementinvolvement
3. Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
4. Develop teams to ensure timely resolution of inprocess and supplier product technical issues to avoid disruption and ensure continuity of supply
5. Serve as a site leader for GQO quality processes
6. Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations
7. Establish standard process to ensure appropriate resolution and management of the responsible task owner
8. Chair meetings required to drive closure of quality issues
9. Manage and provide updates for quality metrics. Implement appropriate enhancements
10. Represent quality processes during internal and external audits
11. Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
12. Recruit, select, and on-board top talent
13. Develop talent within team to increase performance. Actively address performance issues on team
14. Maintain a high level of team engagement
What You'll Need:
15. Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and Internationalrequirements
16. Demonstrate technical knowledge of medical device product lines
17. Demonstrated written, verbal, listening, communication, and team-building skills
18. Demonstrated ability to collaborate effectively with and lead cross-functional teams
19. Demonstrated ability to effectively prioritize and manage multiple project workloads
20. Demonstrated experience with trending and analysis reporting
21. Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes
22. Demonstrated leadership skills
23. Demonstrated process improvement and managementskills
24. Experience with recruiting, people development
25. Influence across the organization
26. Demonstrate an entrepreneurial spirit for driving business forward- relentless drive to deliver on bold and innovative change initiatives
27. Increases business impact by holding self and others accountable for collaborating with global colleagues across functions and divisions, internally and externally
28. A predisposition for coaching and mentoring and a genuine interest in helping others develop
29. Strong emotional intelligence to guide how to achieve through others
30. Exceptional communication skills to influence key decision makers at all levels within the Organisation
31. Great interpersonal skills- a Team player
32. A strong leader with a skill for engaging their team in a common goal
33. Service minded and courageous
Preferred:
34. BS in a science, engineering or related Advanced degree preferred
35. Minimum of 10years experience, 7 years of supervisory experiencepreferred
36. Masters Degree or equivalent preferred
37. Experience working in a regulated environment
38. Good understanding of manufacturing process technologies, and the ability to understand complex processes
39. Experience with delivering results through 6 sigma and lean methods
40. Strong analytical ability, relevant ERP knowledge (preferably SAP, Oracle or JDEdwards) and experience and strong PC skills (MS Excel, Access, etc.,)
Travel Percentage: 20%