Quality Manager

• Serve as the Management Representative with responsibility and authority to create, maintain and modify the QMS.
• Ensure that processes and documentation needed for the QMS are established, implemented and maintained per ISO 13485 and FDA 21 CFR Part 820.
• Manage, plan and perform internal quality audits to ensure compliance to ISO 13485, FDA 21 CFR Part 820 and documented quality management system.
• Regularly report to executive management on the performance of the QMS.
• Promote awareness of regulatory and customer requirements throughout the organization and ensure employee compliance to those requirements.
• Provide leadership and direction to the plant in relation to all QA matters, including quality systems and compliance, material disposition, etc.
• Ensure quality participation in planning and execution of new products introductions including advising on validation and qualification strategy etc.
• Utilize formal problem solving techniques to resolve product and/or process related issues by implementing sustained improvements.
• Ensure timely review of LHR and release of finished products upon completion of testing and inspection.
• Utilize data to drive decision making, ability to drive value add quality initiatives and focus on Performance / Metrics data for preventative and corrective action measures.
• Drive and implement continuous improvements in quality area, and participate in related cross- functional projects.
• Ensure appropriate management of the sites Quality System functions (CAPA, Deviations, NCMR/MRR, Doc Control, Supplier Controls, Complaints, Audits etc).
• Ensure Quality records are complete and accurate as well as Quality Control operations are effective and efficient
• Be responsible for failure appraisal and analysis (internal and external)
• Ensure all corrective and preventive actions are developed and effective to resolve the non- conformances found
• Support regulatory agency and customer quality audits.
• As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.
• Work with suppliers of both raw materials and services, to improve product quality and/or resolve quality issues
• Review and approve all suppliers of components, raw materials, products and services which forms part of the final product and which directly affect the product quality. Assist in the assessment / certification of critical suppliers
• Develop site-wide GMP and related training programs appropriate for all levels of staff to increase the awareness of quality and improve quality standards
• Assists other Company sites, as required, in support of overall Corporate Quality goals and objectives

SUPERVISORY RESPONSIBILITIES: Oversees and manages the Quality Engineering, Quality System, Quality Control and Document Control group including document review. Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding, coaching and disciplining employees; addressing complaints and resolving problems

• Minimum 10 years of progressive responsibilities in quality assurance and control in medical device manufacturing or equivalent. In depth experience in medical device manufacturing, quality systems, quality assurance, quality control.
• Bachelor of Science or Engineering Degree (eg. Biomedical, Mechanical)
• Robust and thorough knowledge and understanding of ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives and able to interpret and direct these requirements
• Strong knowledge of GMP requirements in a regulated manufacturing environment
• Proven management skills
• Computer literate in Microsoft Office applications
• Demonstrated proficiency utilizing engineering tools (i.e. FMEA, DOE, SPC, statistical tools, etc.)
• Demonstrated knowledge and proficiency in process analysis, problem solving skills and improvement using process flow and Lean Manufacturing methods
• Ability to perform activities to support product development, manufacturing, and product release as identified by Senior Management
• Excellent technical writing and verbal communication skills
• Ability to work with all levels of Company personnel
• Must be able to travel periodically to company suppliers, customers and/or sister sites
• While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Controlled Environment (Class 100K cleanroom) and office area.