• Manager, Quality Systems

    Posted Date 2 weeks ago(1/7/2019 4:18 PM)
    Job ID
    2019-2098
    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 Systems will be responsible for delivering all aspects of the Quality Assurance function 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 Quality Management System for all On-X products, processes, and systems supporting the Austin Site. Manage an effective team of Quality Assurance 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 Quality Management System. Develop and manage good working relationships with Engineering, Quality Control, Purchasing, Regulatory, and Manufacturing personnel as well as with other global CryoLife sites. Apply and maintain US and International standards and regulations.

    Responsibilities

    • Review, update, and implement changes to policies and procedures to ensure compliance to US and International regulations and standards (e.g. 21 CFR 820, EN/ISO 13485, MDD, Canada, Brazil, etc.).
    • Provide leadership, direction, management, and development of Quality Management Systems (Quality Systems, Audits, CAPA, Complaints, Device Tracking, Document Control, Software, Training, Metrics) to ensure and maintain compliance, strategies, and objectives for the On-X products, processes, and systems.  Establishes objectives and creates and implements action plans.
    • Manage, coach, and develop a high performing Quality Assurance team that meets objectives and delivers results, guides the organization for strategic and tactical issues, and implements continuous improvements.
    • Implement all Quality Assurance processes to support site and all On-X product lines.
    • Lead Quality Management Systems integrations and complex compliance improvements initiatives at site and global level.
    • Generate, review, approve, and/or execute changes and/or validations for Quality Systems to ensure compliance to US and International requirements for Quality Systems activities.
    • Develop and lead efforts to assess and implement required Quality System changes and improvements through gap assessments, Quality Plans, remediations, and/or integrations.
    • Serve as Audit Quality Administrator and subject matter expert during internal and external audits/inspections in Quality Systems and Quality Assurance areas.
    • Effectively identify and advise the Director, Quality Operations of all significant quality issues and improvements.
    • Develop, manage, and deliver Quality training program for Quality Systems and Quality Assurance processes for new and existing employees and on-going site compliance.
    • Develop, manage, and execute Quality audit program, for internal, external, and supplier audits to ensure global compliance (US and International standards and regulations, site policies and procedures) and site capabilities.
    • Develop strategies for timely submission and approval of verification and validation plans and protocols associated with process and systems according to US and International standards and regulations (e.g. QSR, ISO, MDD) and site policies and procedures.
    • Lead site CAPA, Document Control, and Software programs.
    • Lead Non-Product Software programs for quality implementation, maintenance, and integration (e.g. Pilgrim, SAP).
    • Manage Change Control process to ensure efficiency and compliance to Quality System for US and International requirements for site activities for all On-X products, processes, and systems.
    • Serve as lead project manager for Quality Assurance process improvements and integrations.
    • Lead and maintain Quality oversight of processes to meet compliance for non-conformances, corrective/preventive actions, and complaints for all On-X products, processes, and systems.
    • Provide authoritative guidance about Quality Systems and lead project management to support teams and Quality Assurance personnel.
    • Supports site Management Representative responsibilities and as designee if required.
    • 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 Quality performance to meet goals and deliverables.
    • Lead Quality support for Field Assurance, Clinical, and Regulatory groups for Quality Systems.
    • 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 Assurance budgets to meet and exceed ongoing company deliverables.
    • Represent the compliance function on all interdisciplinary project/program teams as necessary.
    • Perform other duties as assigned by Quality Operations Director, associated with role as Quality Assurance professional to ensure compliance and support current business needs.
    • 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
    • Must be able to make decisions related to Quality Management System and product and release of 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.
    • Execute all responsibilities with the highest degree of professional and ethical behavior.

    Qualifications

    • Bachelor's degree required. Life Sciences or related field preferred.
    • 5+ years in medical device industry
    • 5+ years managing a Quality Assurance and Operations team in the medical device industry with a history of maintaining US and International compliance.
    • 5+ years experience leading and implementing complex processes/systems, site expansions, and remediating/integrating processes at global site level.
    • 3+ years Project Management experience influencing diverse, cross-functional teams.  
    • 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.
    • 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.
    • Strong working knowledge of Quality Management Systems, Validation, Software, Manufacturing and Distribution process controls, Complaints, and CAPA processes.
    • Possess advanced understanding of business and financial impact of projects, with experience managing budget and performing cost analyses.
    • Must be able to manage a high volume of responsibilities, be able to effectively manage and prioritize competing projects and deliverables with agility.
    • Must be able to provide and implement solutions to quality problems. 
    • Well-developed written, oral, interpersonal, and organizational skills required.
    • Ability to seek and deliver honest feedback, be committed and accountable to achieving team goals and abide by team decisions.
    • Ability to work effectively in a fast-paced and dynamic environment.
    • Experience managing Software validation is required. 
    • Experience leading internal and supplier improvements for automation of processes and/or systems is required.
    • Experience with US and International regulations and standards related to medical devices are required.
    • Proven ability to maintain key quality metrics/indicators to track compliance performance and analyze data to implement improvements and streamline processes and procedures.
    • 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 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 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 policies and procedures.
    • Experience with Microsoft Office Suite (Word, Excel, Access, Project Management, Visio) required.
    • Experience with Minitab and/or JMP a plus.
    • Experience with SAP and Pilgrim software required. 
    • Lean Manufacturing Certification  a plus.
    • Auditor Certification required. Certified Quality Engineer a plus.
    • 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 twenty (20) pounds
    • Travel approximately 10% 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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