Job Summary
In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In his position, you will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset.
Essential Duties and Responsibilities
1. Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.
2. Direct reports include quality control supervisors
3. Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude.
4. Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.
5. Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.
6. Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
7. Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.
8. Identifies and develops opportunities to improve existing processes and procedures
9. Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
10. Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
11. Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished.
12. Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required.
13. Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.
14. Exhibits regular, reliable, punctual and predictable attendance.
15. Creates, prepares, implements and improves Quality Control KPIs metrics.
16. Determines/sets Goals and Objectives for the Quality control organization and training programs for team's development purposes.
17. Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
18. Ensures equipment is up to date on Preventive maintenance and calibration activities.
19. Maintains the QC area well organized with a 5S mindset.
20. Other duties as assigned
Additional Responsibilities
21. Participate in special project teams as assigned.
22. Performs other duties as assigned based on business needs.
23. Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
24. Exhibits regular, reliable, punctual and predictable attendance.
Education
25. Associate's Degree Associate's Degree in Technical or Engineering required or
26. Bachelor's Degree Degree in Technical or Engineering preferred
Work Experience
27. Minimum 8 years previous experience in Quality Control required and
28. Experience in FDA regulated environment, pertinent to ISO 15378 preferred
Preferred Knowledge, Skills and Abilities
29. Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP
30. Able to comply with the company’s safety policy at all times
31. Able to comply with the company’s quality policy at all times.
32. Support and contribute to Lean Sigma programs and activities towards delivery of the set target
33. Metrology Equipment experience
34. Leadership experience in leading teams preferred
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
35. This job requires decision making based on data analysis
36. Must be able to generate, express, and exchange new ideas
37. Must be able to understand direction and adhere to established procedures
38. Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
39. Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
40. Read and interpret data, information and documents
41. Must maintain the ability to work well with others in a variety of situations
42. Must be able to multi-task, work under time constraints, problem solve, and prioritize
43. Ability to make independent and sound judgments
44. Observe and interpret situations, analyze and solve problemsAdaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.
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