• Manager, Quality Engineering & Quality Control

    Posted Date 2 months ago(1/7/2019 4:41 PM)
    Job ID
    2019-2099
    Job Location
    US-TX-Austin
    # of Openings
    1
    Category
    Quality Control
  • Introduction

    Is This The Role For You?

     

    We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

     

    If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

    Position Overview

    The Manager Quality Engineering and Quality Control will be responsible for delivering all aspects of the Quality Engineering and Quality Control functions on an on-going basis in alignment with Quality Management System to ensure compliance and meet business needs and customer expectations. Design, improve, and maintain efficient product life cycle processes for all On-X products. Manage an effective team of Quality Engineering and Quality Control personnel, accountable for compliance of Quality System Requirements (US and International Standards and Regulations) and process improvement methodologies for all On-X product lines. Provide leadership through outstanding people skills and collaborative approach. Maintain direct oversight of manufacturability of On-X products and supplier deliverables and Quality investigation into On-X customer complaints. Develop and manage effective working relationships with Engineering, Quality Assurance, Purchasing, Regulatory and Manufacturing personnel as well as with other global CryoLife sites. Apply and maintain US and International standards and regulations.

    Responsibilities

    Essential Functions and Responsibilities:

    • Provide leadership, direction, management, and development of Quality Engineering and Quality Control strategies and objectives for the Design, Sustaining Engineering, Manufacturing, and Inspection processes. Establishes objectives and creates and implements action plans.
    • Manage, coach, and develop a high performing Quality Engineering and Quality Control team that meets objectives and delivers results, guides the organization for strategic and tactical issues, and implements continuous improvements.
    • Develop, manage, and deliver training programs for Quality Engineering and Quality Control processes for new and existing employees and on-going site compliance.
    • Manage supplier qualifications and perform detailed audits to ensure global supplier compliance and capabilities, including reconciliation of inspection methods and evaluation of proposed supplier changes for product development and sustaining activities.
    • Develop strategies for timely submission and approval of verification and validation plans and protocols associated with product/process according to US and International standards and regulations (e.g. QSR, ISO, MDD) and site procedures.
    • Manage sterilization processes [environmental monitoring, sterilizers, and sterilization (gamma, ETO, and steam) validation].
    • Implement all Quality Control inspection processes (in process, final, and product release) for all On-X products.
    • Review and approve Change Control submissions to ensure efficiency and compliance to Quality System for US and International requirements for Product Development and Sustaining activities for all On-X products.
    • Must be a hands-on leader and practical thinker, able to identify and come up with solutions and roll-up sleeves to get things done.
    • Serve as lead project manager for Quality Engineering and Quality Control process improvements and integrations.
    • Lead Quality investigation of non-conformances, corrective/preventive actions, and complaints for all On-X products, processes, and systems.
    • Incorporate US and International regulations and standards through the product life cycle, designing and developing required inspection and process control methodologies.
    • Manage Quality oversight of hazard and risk analyses for new products and sustaining products, including DFMEA and PFMEA.
    • Provide authoritative guidance about Six Sigma principles (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis) as well as guidance on Design Control elements to Product Development team members and Manufacturing Staff.
    • Serve as Audit Quality Administrator and subject matter expert during internal and external audits/inspections in Quality Engineering, Quality Control, Validation, Statistical methods, Sterilization, Design Control, and Risk Management.
    • Develop strong cross-functional relationships and serve as main point of contact for Engineering, Manufacturing, and Regulatory teams, partnering with company management, global partners, and external suppliers to ensure performance to meet goals and deliverables.
    • Lead Quality support for Field Assurance, Clinical, and Regulatory groups for complaint investigations, field actions, clinical evaluations, and regulatory submission processes.
    • Manage key quality metrics/indicators to track compliance performance and analyze data to implement improvements and streamline processes and procedures.
    • Develop and manage responsibility of Quality Engineering and Quality Control budgets to meet and exceed ongoing company deliverables.
    • Perform other duties as assigned by Quality Operations Director, including supplier site audits and general corporate functions associated with role as a Quality Engineering and Quality Control professional to ensure compliance and support current business needs.

    Additional Responsibilities

    • Maintain open lines of communication and effectively deliver feedback to direct reports and dotted-line personnel.
    • Relate to other people beyond giving and receiving instructions: (a) can get along with co-workers or peers without exhibiting behavioral extremes; (b) perform work activities requiring negotiating, instructing, persuading or speaking with others; and (c) respond appropriately to criticism from a supervisor
    • Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency
    • Ability to understand and apply relevant regulations, procedures, guidelines, etc., to products, processes, and systems.
    • Must be able to make decisions related to product quality and release of On-X materials and products.

    Qualifications

    • Bachelor's degree in Engineering field required.
    • 5+ years experience in medical device industry 
    • 5+ years managing a Quality Engineering and Quality Control team in the medical device industry with a history of successful participation in Product Development teams and effective project management.
    • 5+ years experience leading and implementing complex processes/systems, site expansions, and remediating/integrating processes at global site level.
    • Proven ability to develop high performing individuals and drive team member engagement. Ability to collaborate with and support team members, coordinate interdepartmental activities and resolve individual conflicts and issues.
    • Ability to develop comprehensive project plans to lead multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and other support personnel and solving project-related conflicts and issues.
    • Ability to lead risk management, DFMEA, and PFMEA sessions is required
    • Experience managing sterilization programs [environmental monitoring, sterilizers equipment, sterilization (gamma, ETO, and steam) validation, and testing/sterilization suppliers], inspections, and product release. 
    • Possess advanced understanding of business and financial impact of projects, with experience managing budget and performing cost analyses.
    • Experience leading internal and supplier improvements for inspections and automation of equipment, processes, and/or systems.
    • Ability to garner trust from direct reports and team members, seeking and delivering honest feedback. Must be committed and accountable to achieving team goals and positively influencing team decisions.
    • Ability to work effectively in a fast-paced and dynamic environment.
    • Strong working knowledge of Design Controls, Validation, Software, Manufacturing process controls, Complaints, Non Conformances, and CAPA processes.
    • Experience with ISO 14971, Usability Engineering, ISO13485, MDD, and 21CFR Part 820.  Understanding of other US and International regulations and standards related to medical devices is required.
    • Proven ability to maintain key quality metrics/indicators to track compliance performance and analyze data to implement improvements and streamline processes and procedures.
    • Demonstrated successful application of analytical quality tools including Six Sigma, Lean, SPC, and statistical methods to diagnose and correct improper quality control practices, with experience in CMM Programming, Gage R&R and Inspection Plan development required. DFSS training preferred.
    • Focused, target driven with a positive, can-do attitude
    • Independent self-starter, motivated and able to positively motivate others, with ability to organize and prioritize multiple tasks.
    • Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action plans
    • Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing/inspection procedures
    • Experience with Microsoft Office Suite (Word, Excel, Access, Project Management, Visio) required.
    • Experience with Minitab and JMP required.
    • Experience with SAP and Pilgrim software required. 
    • Lean Manufacturing Certification required
    • Auditor Certification required. Certified Quality Engineer preferred
    • Required to read, write and speak English with good command of the language, follow verbal and written instructions.

    While performing duties of this job, the employee is regularly required to:

     

    • Talk, hear, sit, stand, bend, reach and move about facilities
    • Sit or stand for extended periods of time
    • Lift, bend forward with and/or move up to thirty five (35) pounds
    • Travel approximately 15% of the time

    Company Info

    Who We Are.

    CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

     

    CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

     

    CryoLife is an Equal Opportunity/Affirmative Action employer.

    CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

     

    Reasonable Accommodations
    CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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