Manager, Quality Engineering, AIX

The Manager, Quality Engineering is responsible for personnel engaged in New Product Development & Sustaining Engineering with a focus on AIX Products.  The Quality Engineering responsibilities report into this role.

This role will set strategic direction to meet short-term and long-term goals through budget management, process definition and refinement, in-house capital equipment resource planning, and KPI management.

This role will interface internally with VE, RA, MKT, R&D, Calibration, QC, Supply Chain, Inventory Control, Planning, Purchasing.

Essential Duties and Responsibilities

• Hire and retain highly qualified staff and provide coaching, mentoring, career development and ongoing performance feedback.
• Assign and review project work of staff, set work and resourcing priorities, and review/course correct the output of project deliverables
• Implement data collection system for relevant metrics integrated within ATEC Quality Objectives.
• Implement forum for ongoing technical training related to Validation Engineering skills & techniques to match needs of the business.
• Manage the team responsible for verification and validation activities for new product development & sustaining engineering projects.
• Provides individual Verification and Validation Engineering expertise for Design Controls to ensure efficient, effective, and compliant new product launches including requirements evaluation, end-to-end traceability and the establishment of V&V Plans.
• Manual and automated system test method development and qualification.
• Represent Validation Engineering when collaborating with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles of Software Validation), including but not limited to Requirements Specifications, Validation/Test Plan, Testing, Integration Test Scripts, Operational/System Test Scripts, Validation Summary Reports.
• Influence Risk Management efforts in accordance with ISO 14971 and IEC 62304.
• Maintain regular and consistent attendance at the normal worksite.
• Other duties as assigned.
  

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Technical Qualifications:

• Firm understanding of the FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)
• Extensive knowledge of IEC 62304, IEC 60601 requirements
• Knowledgeable with ANSI C63:27 American National Standard for Evaluation of Wireless Coexistence requirements
• Proficient knowledge of ISO 14971 requirements.
• Proficient knowledge with Requirement & Test Case management utilizing ALM software.
• Proficient knowledge with requirement elicitation, traceability, and verification.
• Proficient knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) including competency using desktop lab equipment (function generators, oscilloscopes, etc)
• Proficient knowledge of biocompatibility requirements, SPC, DOE, probability and statistics.
• Extensive demonstration of successful testing and validation of medical products through full life cycle including writing protocols, reports, and procedures required
• Strong ability to demonstrate comprehensive knowledge of project management techniques to ensure predictability of complex cross-functional projects.
• Strong ability to demonstrate technical expertise and communicate with internal and external customers and executive management.
• Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment.

Management

• Ability to measure project results (impact to business) using appropriate systems, tools, and techniques.
• Work within a defined system to publish milestones, track progress, and facilitate risk mitigation discussions.
• Ability to work independently as a project manager and manage a working cross-functional team. 

Personal Attributes:

• Self-starter, works independently and maintains positive, enthusiastic attitude with a high-level of attention to detail/quality.
• Ability to handle competing priorities and a broad variety of tasks simultaneously under high pressure and ambiguity.
• Excellent oral and written communications skills with the ability to interface and influence at all organizational levels
• Strong facilitation skills, confident communicator (both verbally and written) with all levels of an organization and diverse audiences.
• Ability to develop and maintain strong working relationships with internal and external customers and suppliers

Education and Experience

• Bachelor’s degree from four-year College or university in Engineering, or equivalent experience.
• Minimum of 7 years of experience in a regulated industry in disciplines of Quality Engineering, Systems Engineering.  Medical device experience preferred.  

Certificates, Licenses, Registrations

• ASQ CSQE/CQE preferred.
• ASQ CMQOE preferred.                

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $125,000 to $135,000 Full-Time Annual Salary