Program Manager, Quality Assurance
Position
Summary:
This position will lead and provide strategic direction to the Middletown, VA site for Quality Projects and ensure full compliance of product and systems to regulatory requirements. The candidate will be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable improvements. Key
Responsibilities:
Responsible for coordination of assigned Quality Projects and driving a quality mindset within project teams Establish, maintain and lead the site portfolio of impactful quality / regulatory projects at the site. Utilize the company Practical Process Improvement process to create project charters, establish clear problem statements and drive project teams to deliver solution sets with most impact to the business. Drive cross functional project teams to flawless project execution using the risk assessment process to manage priorities and collaboration with cross functional teams. Coach and train team members on Quality methods and tools Coordinate and drive Problem solving activities within the projects. Schedule/chair routine team meetings with published minutes to ensure the project is on track. Maintain project schedules by developing project plans including estimating time and establishing deadlines. Establish, monitor and report appropriate metrics to monitor projects. Liaise with project stakeholders on an ongoing basis. Support the hiring, training and develop Quality Assurance staff to ensure high performance and continuity of staffing. Act as resource during FDA inspections, Notified Body, customer audits and other third-party Quality System evaluations. Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement and role modeling the values. Minimum Requirements/
Qualifications:
Position requires a 4-year degree in a technical/science area; an advanced degree is preferred. Five or more years in a regulated industry with 2 or more years in a management position is also required. Six sigma experience Significant experience with quality systems, preferably in an IVD/Medical device environment. Incumbent must possess excellent interpersonal and communication skills. Critical Hiring Criteria:
Excellent relationship building and persuasion skills with the ability to motivate and influence others. Proven ability to work with people in a diverse work environment. Well-developed verbal skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and/or technical criteria. Must be skilled and experienced in acting in a consultant role, with a demonstrated record of overcoming resistance to change, and driving the adoption of new business processes from a position of indirect or informal authority Communicate openly and honestly Focus on growth Champion employee development
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
This position will lead and provide strategic direction to the Middletown, VA site for Quality Projects and ensure full compliance of product and systems to regulatory requirements. The candidate will be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable improvements. Key
Responsibilities:
Responsible for coordination of assigned Quality Projects and driving a quality mindset within project teams Establish, maintain and lead the site portfolio of impactful quality / regulatory projects at the site. Utilize the company Practical Process Improvement process to create project charters, establish clear problem statements and drive project teams to deliver solution sets with most impact to the business. Drive cross functional project teams to flawless project execution using the risk assessment process to manage priorities and collaboration with cross functional teams. Coach and train team members on Quality methods and tools Coordinate and drive Problem solving activities within the projects. Schedule/chair routine team meetings with published minutes to ensure the project is on track. Maintain project schedules by developing project plans including estimating time and establishing deadlines. Establish, monitor and report appropriate metrics to monitor projects. Liaise with project stakeholders on an ongoing basis. Support the hiring, training and develop Quality Assurance staff to ensure high performance and continuity of staffing. Act as resource during FDA inspections, Notified Body, customer audits and other third-party Quality System evaluations. Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement and role modeling the values. Minimum Requirements/
Qualifications:
Position requires a 4-year degree in a technical/science area; an advanced degree is preferred. Five or more years in a regulated industry with 2 or more years in a management position is also required. Six sigma experience Significant experience with quality systems, preferably in an IVD/Medical device environment. Incumbent must possess excellent interpersonal and communication skills. Critical Hiring Criteria:
Excellent relationship building and persuasion skills with the ability to motivate and influence others. Proven ability to work with people in a diverse work environment. Well-developed verbal skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and/or technical criteria. Must be skilled and experienced in acting in a consultant role, with a demonstrated record of overcoming resistance to change, and driving the adoption of new business processes from a position of indirect or informal authority Communicate openly and honestly Focus on growth Champion employee development
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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