Quality Manager

Title: Quality Manager
Department: Quality
Location: Winston-Salem, North Carolina

Purpose

The Quality Manager position is responsible for developing, establishing, and maintaining QA programs, policies, processes and ensuring quality performance of our products by performing the following duties personally or through subordinate supervisors and/or the management team.

Responsibilities

• Direct and coordinate quality projects of major magnitude and scope and provides significant guidance and approval regarding technical strategies and approaches.
• Develops and monitors department budgets to maximize investments, increase efficiencies and ensure the quality of our product, and drives the development of department tools and methodologies.
• Assures the adequate implementation of management objectives.
• Develops strategic operational planning, make recommendations for resource allocations and provides key performance indicator (KPI) information to management on product and system performance.
• Establishing long-range objectives and specifying the strategies and actions to achieve them (i.e. develop policies, procedures, methods, and/or standards).
• Communicating goals, objectives, key performance indicator (KPI) data, etc. with supervisors, peers, or subordinates through meeting, telephone, in written form, e-mail or in person.
• Manage staff, preparing work schedules and assigning specific duties and tasks.
• Coaches and develops team – identify the developmental needs of others to improve their knowledge, skills, attaining career goals.
• Ensures processes needed for the QMS are established, implemented, and maintained.
• Manages the following functions or tasks directly or through subordinates: Management Review, Supplier Quality / SCAR, Calibration, NCM Control, Document Control, CAPA, External QMS Audits (Customer; Notified Bodies), Corporate Internal QMS Audits, In-process Inspection/SOther duties and assignments as directed by Management.
• Acts as the management representative for Winston Salem.

Requirements

Education:

• Bachelor of Science Degree in Quality Engineering (or related discipline)

Experience:

• 5-7 years’ experience
• Preferred: cGMP/cGDP Experience; Six Sigma Certification (preferred); ASQ CQE Certification (preferred)
• Quality Engineering (i.e. DOE, Inference Tests, Normality/Capability Analyses, Correlation Studies, Gage RR, etc)
• Information Analysis (Mini-Tab experience preferred)
• ISO 9001 / ISO 13485 (current revision)

Competencies

• Excellent organizational and oral/written communication skills are required.
• Maintain a positive work atmosphere by behaving and communicating in a manner that fosters a professional environment for clients and associates.
• Able to interface effectively at all levels and communicate effectively as part of a team.
• Working knowledge of Smartsheet, and Microsoft Office Suite
• Routine, direct interaction with shifts other than 1st shift is expected and requires temporarily shifting work hours to accommodate.