Sr. Manager, Quality
The Senior Manager, QA Scottsdale serves as the Management representative as defined by ISO 13485:2016 section 5.5.2. Interaction with both internal and external customers, as well as quality and regulatory agencies, to achieve department and company goals. Assure compliance of the plant processes and products to established industry standards, specifications, and procedures, ensure quality system is implemented and its integrity maintained.
location: Scottsdale, Arizona
job type: Permanent
salary: $125,000 - 135,000 per year
work hours: 9 to 5
Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact.
- Establish and execute Quality strategic plans and policies for Scottsdale Operations site and provide input into the QE objectives for the Scottsdale Development Center.
- Oversee and develop the corporate Facility Audit Program to help assure compliance to internal/external requirements, including customer requirements and strategic initiatives.
- Conduct training and re-certification as appropriate for quality and other personnel in relation to improvements of the quality system
- Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Complaint, Doc Control, Lot Release).
- Lead Regulatory/customer audits
- Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a 'culture of quality'.
- Assure that the Quality System is compliant with applicable Regulatory and Industry standards, specific to Medical Devices.
- Ensures timely resolution to customer inquiries (audit findings and complaints)
- Maintain Quality Metrics to demonstrate areas of improvement and state of compliance
- Conduct Management Reviews as required by procedure
- Serve as Management Representative for the SCO site
- Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
- Provide leadership and guidance to Quality Operations team, Quality Engineers (both SDC & SOC)
- Manage Quality Staff at site to assure knowledge and execution of site Quality System
- Assure proper use of change management associated with validated processes
- Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
- Drive continuous quality improvement projects and global harmonization initiatives
- Maintain clear communication paths with stakeholders
- Performs other duties as assigned based on business needs
- Bachelor's with emphasis in Engineering or Science.
- Master's degree preferred with an emphasis in Engineering, Science, or Business.
- More than 10 years of work-related experience required. 2-3 Years of Supervisory experience required.
- Superior organizational and leadership skills with ability to help team grow and thrive
- Experience with Customer interface and meeting customer expectations.
- Demonstrate team building and problem-solving skills
- Ability to effectively prioritize and escalate issues
- Working familiarity with Project Management Tools and Quality Risk Management.
- Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc)
- Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals and/or Plastics manufacturing.
- Demonstrated people skills specific to team building, problem solving and conflict resolution.
- Excellent presentation, writing, verbal, computer, interpersonal and communication skills.
- Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
- Manages competing demands, makes timely and sound decisions, even under conditions of risk.
- Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and team building.
- Effectively influences actions and opinions of others.
- Must possess knowledge of regulatory and governmental guidelines and requirements (FDA, ISO, cGMP, GLP, OSHA).
- Ability to perform effectively and efficiently in a fast-paced environment.
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.