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    Quality Assurance Manager - New York, United States - Caire

    Caire
    Caire New York, United States

    6 days ago

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    Description
    Come join a dynamic Medical Supply manufacturer on the move. O2 is what we do
    Leading global manufacturer of oxygen therapy and cardiorespiratory diagnostic equipment, CAIRE Inc.

    has operations around the globe with its new Global Service Headquarters in Ball Ground, GA, this move by the company is designed to advance long-term plans to enhance service and support for home and durable medical equipment providers everywhere.


    The Quality Manager supports the development and execution of a holistic quality program in collaboration with CAIRE's global headquarters operations located in Ball Ground, GA.

    The Quality Manager leads a team of quality professionals that drives key processes within Quality Engineering, Supplier Quality Engineering, Incoming Inspection, Metrology, and Radiology.

    This position will report directly to the Director of Ball Ground Operations and Global Quality.

    Essential Functions
    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Lead and manage the Ball Ground quality team, providing guidance in the implementation of plans and procedures that drive achievements of quality goals.

    Manage team performance; addressing disciplinary issues, hiring, assisting people with career development, communicating information to direct reports, and passing information up the management chain, administrative processing, and maintaining trust and confidentiality; and ensuring the team is aligned with and accomplishing goals/objectives.

    Lead a team that is focused on the departmental strategy and vision to ensure adherence with customer expectations, enforce consistent and continual improvements, and monitor global quality metrics.

    Manage the collection and analysis of quality information from multiple sources to help develop long-term quality strategy and programs.
    Leads production process analyses, ensuring quality standards are met and making recommendations for quality improvements.
    Develops and implements program quality plans and procedures.
    Embed and sustain a culture of awareness, inquisitiveness, and persistence around process and product quality improvements.

    Foster a safety-first mentality while improving efficiencies through the improvement of process flow, elimination of waste, and cost reduction through leadership, example, and training.

    Ability to influence and build strong and trusted working relationships with internal and external business stakeholders at all levels.

    Establishes and ensures supplier quality standards are acceptable and sustainable through the deployment of inspection processes; both at incoming and throughout the manufacturing processes where appropriate.

    Interface with supply chain to improve and confirm purchase part quality and reliability.
    Ensure critical suppliers are held to the highest standards and are monitored appropriately through audit programs.
    Facilitate cooperation with operations, engineering, and sales to improve purchase part quality and reliability.
    Communicate effectively with internal and external customers.

    Prepare periodic reports identifying root cause(s) for product returns, identify corrective action(s), and make recommendations to improve overall longevity of product.

    Provide leadership and the application of problem-solving initiatives through systemic tools such as lean manufacturing and six sigma.
    This is a hands-on position for an individual who understands medical product demands, manufacturing workflow, and quality processes.
    Other duties and responsibilities as assigned.
    Competencies

    • Excellent personal skills in leadership, coaching and both written and verbal communication.
    • Proven success in leading diverse groups of engineers, managers, and technicians.
    • In depth understanding and experience with Quality Systems, including ISO, MDD, and FDA requirements.
    • General knowledge of pressure vessel codes.
    • Experienced understanding of business software use, CAD systems, and Quality & Design Control systems.
    • Thorough knowledge of quality standards, engineering design principles, and process flow evaluation and improvements.
    Supervisory Responsibility
    Yes

    Travel
    Yes, Travel up to 10% per year. Some of travel is international.

    Education and Experience

    • Minimum B.S. degree in engineering or other technical discipline, MS or MBA preferred.
    • Successful experience leading projects, and juggle multiple business demands.
    • Minimum of five years' quality managerial experience manufacturing complex electro-mechanical products.
    • Ability to motivate, mentor, and inspire a diverse skillset technical team.
    • DMAIC and Lean Six Sigma experience, black belt preferred.
    • Prior responsibility for validation of processes, equipment and products.
    • Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk/Cp.
    • Familiarity with mechanical CAD (Solidworks and AutoCAD) and MS Project software.
    • Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
    • Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
    • Prior experience with the development of control plans, DMRs and Work Instructions for medical devices and clinical application of surgical instruments is a plus.
    • Ability to work in a Matrix org structure with cross functional Value Streams.
    • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred.
    Additional Eligibility Qualifications


    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

    Duties, responsibilities, and activities may change at any time with or without notice.

    What we offer:
    Base and Bonus compensation.
    Matching 401k with discretionary profit sharing
    PTO and Paid Holidays
    Paid Long and Short-Term Disability
    3 types of Health plan offerings in which to choose.
    Dental/Vision insurance
    Other Ancillary benefits
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