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Quality Engineer II

3 months ago

Wayne, United States Getinge 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.

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

 

 

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We focus on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals to join our team.

 

We currently have an open position for a Quality Engineer II.  This position is responsible for and plays a critical role in ensuring the quality and compliance of designed medical devices throughout the product development lifecycle. This role involves working closely with the cross-functional product engineering team to identify and mitigate risks, implement quality controls, and ensure compliance with industry regulations and standards. Responsible to develop, improve and implement quality processes, conduct risk assessments, and ensure compliance to design controls requirements. The Quality Engineer II will also support continuous improvement initiatives and contribute to the development of quality assurance processes and documentation.

 

Job Responsibilities and Essential Duties

  • Ensures assigned product development and/or design change initiates are executed in accordance with Design Controls procedural requirements. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR and other relevant regulations and standards, specifically for Design Controls and Risk Management.
  • Develop and implement quality plans, procedures, and protocols for new product development.
  • Participate in design reviews, risk assessments, and failure mode and effects analyses (FMEA).
  • Collaborate with the product development team to ensure that quality considerations are integrated into the design and development processes.
  • Support design verification and validation activities, including protocol development, execution, and report generation.
  • Provide input on design control documentation, ensuring that it meets quality and regulatory requirements.
  • Conduct risk assessments and manage risk management files throughout the product lifecycle.
  • Identify and mitigate potential quality and compliance issues through proactive risk management strategies.
  • Develop and implement test plans, including defining acceptance criteria and ensuring proper test method validation.
  • Supports determination of sampling plan and test strategy help ascertain product/ process reliability for the assessed risk.
  • Oversee and perform testing and inspection activities to ensure product quality and compliance. Analyze test data and report findings to the product development team.
  • Works with cross-functional team (R&D & Supplier Quality) to ensure critical to quality requirements are defined and ensure that supplied materials and components meet specifications.
  • Support cross-functional teams with quality-related expertise and guidance.
  • Supports design reviews, verification, and validation activities. Ensures Design History File (DHF), Technical Files, and Device Master Records (DMRs) contents are developed, controlled, and maintained.
  • Facilitates the investigation of component issues (via complaints and/or improvement) with Product Engineering teams, as needed. Initiates and/or supports CAPAs and may lead the investigation/corrective action process.
  • Support Sustaining Engineering design changes and New Product Development projects as necessary.
  • Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA). Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
  • Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
  • Maintains close oversight and timeliness of initiated Field Action for assigned project, i.e. ensure Filed Action customer communication is developed, regular updates are submitted to authorities, maintains Field Action Plan.
  • Support both internal and external audits as an SME for Design Controls and presents records of activities related to New Product Development and Design Changes.
  • Participate in continuous improvement initiatives to enhance product quality and process efficiency. Identify opportunities for improvement and implement best practices in quality engineering and product development.
  • This is not an inclusive list of job responsibilities.

Required Knowledge, Skills and Abilities

  • A bachelor’s degree in engineering, Science, or other related field or equivalent is required. ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt (SSGB) or other applicable certifications are a plus.
  • 5 years’ experience in Quality or Engineering.
  • Experience in a medical device or pharmaceutical industry. Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
  • Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
  • Knowledge of application & selection of Sampling Plans, set-up of Design Trace matrix and DHF.
  • Project management and leadership experience is desirable.  Ability to work effectively in a cross-functional team environment.
  • Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
  • Strong analytical and problem-solving skills. Excellent communication and interpersonal skills.
  • Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
  • Ability to review and understand technical standards and their requirements for products.

Salary range: $85k-$95k

#LI-LG1

 

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.