Manager Quality Compliance

1 week ago

Wayne, United States Getinge Full time $124,000 - $150,000
With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Manager, Quality Compliance is responsible for leading the Cardiac Surgery/Vascular Intervention Quality Compliance group. This position will have a responsibility for providing support for maintenance of quality systems, Internal audit program, CAPA process, management of 3rd party audits (FDA, ISO, other), FDA inspection response to 483 observations and periodic updates. This position partners with Quality leaders as well as representatives/leaders from the other cross functional groups on Quality Management System improvements. Develops and manages the department to assess and ensure compliance to the FDA Quality System Regulations CFR Part 820, ISO 13485 Quality System Standard, MDD, CMDR, WHLW, ANVISA, JPAL and other applicable regulations. The position will lead the quality compliance team and coordinates efforts to effectively maintain quality system to the applicable regulations and standards. This position will manager 3 to 4 employees.

The position reports to the Wayne Getinge Headquarters upto 4 days a week.

Job Responsibilities And Essential Duties

  • Direct the development, maintenance, and rolling review of compliance and Quality Management systems.
  • Responsible for assuring the business functions operate in compliance with applicable domestic and international requirements, laws, and guidance.
  • Provide quality review and approval, as appropriate, for change notices.
  • Assists with third party quality systems inspections and audits (i.e. FDA, ISO, corporate, etc.)
  • Responsible for directing all day to day compliance activities in support of business objectives:
    • CAPA Process Management
      • Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
    • Internal Audit Management
      • Responsible for internal audit activities in accordance with 21 CFR 820.22.
    • Management Review and Monthly Metrics Meetings
      • Manage the process for QMS monitoring, review, and follow-up activities to ensure early visibility for potential patient and compliance risks.
    • Quality Planning
      • Manage the process for Quality Planning to ensure implementation.
    • Process Non-conformity
      • Own and manage the Process Non-Conformity activities
  • Management of compliance to applicable External Standards and worldwide regulations. Maintain compliance with 21 CFR 820, 803, 806, ISO 13485, ISO14971, and other applicable standards.
  • Write and coordinate responses to External Audits (i.e. FDA Inspection, Corporate Audits, Notified Body, etc.)
  • Manage departmental costs and spending in support of business objectives.
  • Develop and maintain a competent and accountable organization which is positioned to support and accomplish business objectives while maintaining compliance with applicable standards, laws, and guidance.
  • Ensure that all Quality Management Systems are in compliance with external and internal GMP requirements and actively provide strategic direction to support the customer needs and business targets.
  • Strengthen quality awareness, support technical services, and process improvements.
  • Responsible for investigating, identifying, and implementing best in-class Quality Compliance practices Cardiac Surgery Quality Compliance group.
  • Establish credibility and confidence with key internal and external colleagues through regular communication and proven performance.
  • Works collaboratively with internal functional departments (Quality Assurance, R&D, Purchasing, Sourcing, and Operations, other) to accomplish business objectives while maintaining compliance with applicable standards, laws and guidance.
  • Ensure that the conformity of the devices is appropriately checked, in accordance with the Quality Management System under which the devices are manufactured, before a device is released.(To comply with Article 15 of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC).
Minimum Requirements

  • A Bachelor’s Degree in Engineering, Science, or other related field or equivalent combination of education and related work experience is required.
  • A Master’s of Science (or related field) or MBA is a plus. ASQ, CQE, greenbelt or other applicable certifications are a plus.
  • A minimum of ten years of experience in quality assurance, quality compliance, or related functions in a FDA regulated industry or ISO certified organization is required.
  • A minimum of ten years related experience managing quality systems and implementing Quality Management systems in the medical device or pharmaceutical or related industry is preferred.
  • Certified Quality Compliance Auditor certification required for the position
  • Proven experience managing other employees
  • Must have demonstrated presentation aptitude, facilitation skills, and the ability to interact and effectively communicate with senior management and manufacturing staff at all levels.
  • Must be able to lead others in the use of critical thinking, problem solving, and analysis.
  • Must have effective leadership, problem solving, decision making, influencing, and negotiation skills.
  • Must have the ability to assess the impact of quality management strategies on business performance.
  • Must have in depth knowledge of all applicable Quality and Regulatory standards.
  • Proficiency in the Microsoft Office suite.

The base salary for the position is a minimum of $124,000 and a maximum of $150,000 plus 15 % annual bonus

About Us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

  • Compliance Officer

    3 weeks ago

    Wayne, New Jersey, United States Quick Holdings LLC Full time

    Job OverviewThe Compliance Coordinator role is a vital part of our team at Quick Holdings LLC.About the RoleWe are seeking a detail-oriented and organized individual to provide compliance support to our General Manager and Senior Safety and Compliance Manager. This includes documentation, reporting, and training related to safety and regulatory...

  • Quality Manager

    4 weeks ago

    Fort Wayne, United States FXI Full time

    Quality ManagerJob LocationsUS-IN-Fort WayneID2024-3910CategoryEngineeringPosition TypeFull-TimeOverviewBuilding our Future Together. FXI is a leading producer of foam innovation in the Bedding, Furniture, Industrial, Home & Office, Healthcare, and Transportation markets. We have made it our mission to provide tailored solutions that delight our customers...

  • Corporate Compliance Associate

    1 week ago

    Wayne, New Jersey, United States Quick Holdings LLC Full time

    Job Description: As a Corporate Compliance Associate, you will be responsible for supporting the General Manager and Senior Safety and Compliance Manager in maintaining compliance with safety and regulatory requirements. Key tasks include conducting research, analyzing data, and managing confidential information.Main Responsibilities:Work with team members...

  • Manager Design Quality Engineering

    1 month ago

    Wayne, United States Maquet Cardiovascular LLC Full time

    With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. ...

  • Compliance Assurance Specialist

    4 weeks ago

    Wayne, Pennsylvania, United States Vanguard Full time

    **About the Role:**Vanguard is seeking a skilled Compliance Assurance Specialist to join our team. As a key member of our Compliance team, you will play a critical role in ensuring that our operations align with regulatory requirements and industry best practices.**Key Responsibilities:**Develop and implement effective compliance programs to mitigate risk...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Wayne, New Jersey, United States Getinge Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at Getinge. This role will be responsible for ensuring the effective establishment and maintenance of quality systems, supporting quality planning, and coordinating technical activities related to validations.Key ResponsibilitiesDevelop and...

  • Quality Assurance Director

    3 weeks ago

    Fort Wayne, Indiana, United States Creative Liquid Coatings, INC Full time

    Job Title: Quality Assurance DirectorAbout Us: Creative Liquid Coatings, INC is a leading manufacturer of high-quality coatings solutions. We are committed to delivering exceptional products and services that meet the highest standards of quality, reliability, and safety.Estimated Salary Range: $120,000 - $160,000 per annum, depending on experienceJob...

  • Quality Management Professional

    3 days ago

    Fort Wayne, Indiana, United States Brunswick Corporation Full time

    About the Role:We are seeking a highly motivated and experienced Quality Management Professional to join our team at Brunswick Corporation. As a key member of our quality management team, you will be responsible for driving process improvements and ensuring the highest standards of quality in all aspects of our operations. This includes developing and...

  • Home Quality Manager

    1 day ago

    Fort Wayne, Indiana, United States Allen Edwin Homes Full time

    Job SummaryWe are seeking a highly skilled Home Quality Manager to join our team at Allen Edwin Homes. As a key member of our construction management team, you will be responsible for ensuring the quality and completion of new homes in accordance with our company's standards and expectations.The successful candidate will have a strong background in...

  • Quality Assurance Manager

    3 days ago

    Fort Wayne, Indiana, United States SANKO GOSEI TECH Full time

    Job OverviewSANKO GOSEI TECH is seeking a Quality Assurance Manager to lead our quality initiatives and ensure the delivery of defect-free products to our customers. This role will play a critical part in driving continuous improvement, enhancing customer satisfaction, and upholding our company's commitment to excellence.

  • Senior Quality Manager

    3 weeks ago

    Fort Wayne, Indiana, United States SANKO GOSEI TECH Full time

    Sankyo Gosei Tech seeks a Senior Quality Manager to lead our quality initiatives and drive continuous improvement in product and process performance. As a key member of our team, you will be responsible for ensuring the highest level of quality in all our products.Job DescriptionKey Responsibilities:Develop and implement quality strategies to improve...

  • Quality/Accreditation Spec

    3 months ago

    Fort Wayne, United States Parkview Health Full time

    Summary The Quality/Accreditation Specialist (QAS) assists with researching, analyzing, planning, educating, implementing, evaluating and communicating patient safety, performance/quality improvement projects, to support Parkview Health's mission, vision and strategic goals. The QAS oversees and assists in coordination and facilitation of...

  • Senior Quality Management Executive

    3 weeks ago

    Fort Wayne, Indiana, United States Plastic Executive Recruiters Full time

    Job OverviewWe are seeking an experienced Senior Quality Management Executive to lead our quality initiatives across multiple plants in North America.About the RoleThis is a full-time position offering a competitive salary of $145,000 per year.The ideal candidate will have 10 years of experience in automotive manufacturing with strong knowledge of IATF 16949...

  • Quality Engineer

    3 weeks ago

    Wayne, United States EPITEC Full time

    Role and Responsibilities:Communicates effectively and quickly when plant Quality Concern Notifications are issued. Ability to present status of issue resolution to plant management team. Key interface with Quality. Knowledge of supplier’s manufacturing process. Facilitator for visits from supplier's corporate office. Understands whether supplier is design...

  • Land Development Manager

    4 weeks ago

    Wayne, United States Lennar Homes Full time

    Welcome Home! Build your career with Lennar!As one of the nation’s largest builders, Lennar has built over one million new homes for families across America. Since 1954, our communities have catered to all lifestyles and family dynamics, whether you are a first-time or move-up buyer, multigenerational family, or active adult.At Lennar, Everything’s...

  • Land Development Manager

    4 weeks ago

    Wayne, United States Lennar Homes Full time

    Land Development Manager at Lennar Homes summary: The Land Development Manager at Lennar oversees the management of land development projects from planning through infrastructure completion. Responsibilities include managing project schedules, ensuring compliance with local regulations, and coordinating with various stakeholders to facilitate successful...

  • Inspection and Compliance Expert

    2 days ago

    Wayne, Michigan, United States R&M Enterprises of Michigan, Inc. Full time

    About the RoleR&M Enterprises of Michigan, Inc. is looking for an experienced Quality Inspector to ensure the highest standards of quality in our production process.This role involves inspecting incoming components, identifying defects, and implementing corrective actions.The annual salary for this position is approximately $70,000 - $90,000, based on...

  • Home Quality Control Manager

    1 day ago

    Fort Wayne, Indiana, United States Allen Edwin Homes Full time

    About the JobAs a Home Quality Control Manager, you will be responsible for overseeing the construction process to ensure that homes meet our high standards.You will work closely with our construction teams to identify and address any issues that may arise during the building process.Key Responsibilities:Conduct regular site visits to inspect construction...

  • Senior International Trade Compliance Analyst

    2 weeks ago

    Wayne, United States Disability Solutions Full time

    Job Description Because this role involves a combination of collaborative/in-person and independent work, it will take the form of a hybrid work format, with time onsite and remote. Position can be filled at any of the following locations: Arlington, VA; Endicott, NY; Fort Wayne, IN; Greenlawn, NY; Nashua, NH; Reston, VA; or Wayne, NJ.You don’t see it, but...

  • Quality Assurance Specialist

    2 days ago

    Wayne, Michigan, United States R&M Enterprises of Michigan, Inc. Full time

    Job DescriptionR&M Enterprises of Michigan, Inc. is seeking a detail-oriented Quality Inspector to ensure the highest standards of quality in our products.ResponsibilitiesConduct thorough inspections of incoming components and finished products.Identify and report any defects or discrepancies to management.Collaborate with production teams to implement...