Senior Quality Engineer MMS - Wayne, NJ
Develop and execute the Service Quality strategy for the Canada SSU. Maintain positive communications with Health Canada and assist the Business Category Units with attaining and sustaining product licensing.
* Acts as a key driver of change within the organization, supporting peers and leaders by communicating CAPA process improvement efforts to employees and educating team members in understanding how CAPA fits into the organization's continuous improvement initiatives.
* Develop training and train teams on the use of a CAPA process that is based on lean six sigma principles, methodologies and practices.
* Create Standard Operating Procedures to maintain practical, efficient compliance to all Regulatory requirements.
* Create and lead a CAPA Review Board to drive robust discussion of CAPA milestones and timely approvals of milestones.
* Establishes key metrics and an overall scorecard for CAPA processes and results.
* Communicates, interacts and coordinates CAPA efforts with SSU Leadership, Business Leadership, QA Leadership and Operations team.
* Create effective, practical processes for the monitoring and analysis of processes and data to identify and initiate CAPAs.
* Leads CAPA management to ensure that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
* Partner with internal resources to ensure CAPAs are properly performed, documented, and completed in accordance procedures.
* Assess CAPA process and tools for their ability to meet requirements including compliance, effectiveness, and robustness.
* Provides leadership, mentoring, and training to all levels and functions within the SSU Organization in the use of CAPA investigation principles and methodologies.
* Supports all groups within the SSU Americas in the use of the CAPA process, procedures, metrics and reporting.
* Act as Subject Matter Expert on CAPA process to external auditors.
* This is not an inclusive list of job responsibilities.
* Bachelors degree in Engineering, Science or related field is required. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer), Black Belt certification or CQA (Certified Quality Auditor) is desirable.
* Minimum of five years experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years experience is required. Prior experience in a FDA regulated industry or ISO certified organization
* Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
* Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
* Project management and leadership experience is required. Previous experience participating in FDA/customer/corporate audits is preferred.
* Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
* Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
* Must have effective problem-solving, decision making, influencing and negotiation skills as well as the ability to assess the impact of regulatory strategies on business performance.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Getinge is an EO employer - M/F/Veteran/Disability