Quality Assurance Manager

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• Implement a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develop direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitor daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Interact with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interpret and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contribute to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Contribute to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translate department goals into individual objectives and KRAs.
• Identifies, develop and implement processes to improve department performance.
• Monitor departmental activities and records to ensure compliance independent action through critical decision making.
• Provide manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• Direct Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
• Implement improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Ensure sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
• Promote the attainment of group goals by selecting, motivating, and training capable staff.
• Provide leadership to assigned units by communicating and providing guidance towards achieving group objectives.
• Schedule human and material resources within a group or section in conjunction with near-term plans to ensure their availability.
• Carry out operations within an established budget.
• Assignments are expressed in the form of tasks and objectives.
• Generally make day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management.

• Bachelor's Degree or an equivalent combination of education and work experience
• 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.
• 3-5 years in a supervisory/leadership role.
• Class III or II medical device experience.
• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Ability to travel internationally to support international manufacturing sites.
• Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
• Demonstrated and impactful strong project management and people leadership skills required.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel approximately 25%, including internationally.

• 401k matching
• Health insurance
• FreeU education benefit
• Freedom 2 Save student debt program
• Tuition reimbursement

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