Quality Sustaining Engineer

Job Overview

As a Quality Sustaining Engineer, you will play a key role in ensuring that Healthmark product across Getinge’s Infection Control Consumables portfolio meet applicable quality requirements. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products.

You will work cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Operations to support compliant product lifecycle management on Healthmark products for design transfer deliverables and resulting acceptance activities and production and process controls for both Healthmark designed and distributed products.

Job Responsibilities and Essential Duties:

• Support design change transfer deliverables and activities in accordance with FDA Quality System requirements (21 CFR Part 820 / QMSR) requirements for Class I, II devices, EU MDR (2017/745) requirements for Class I devices, and applicable internal quality system procedures.
• Ensures critical-to-quality (CTQ) attributes from product designs are reflected in product and materials acceptance activities, equipment qualification, calibration, PM requirements, validations, and facility production and process controls.
• Provide quality engineering input in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.
• Lead cause-identification and problem-resolution for various types of quality, production or service-related issues. Including product complaints, nonconformance report evaluations of factory issues as well as evaluations of factory caused Out of Box failures.
• Serve as a Quality subject-matter expert for PFMEA and production related risk management files per ISO 14971: 2019.
• Participate in production process work instruction development and review of changes.
• Support internal and external audits by providing clear rationale and objective evidence for role area of responsibilities.
• Ensures comprehensive measurement systems and trending is in place to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects.

Required Knowledge, Skills and Abilities:

• Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills, with the ability to engage effectively at all organizational levels.
• 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

Minimum Requirements: 

• Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred;
• 5+ years of relevant experience in the medical device industry; and have several years of experience in Quality Engineering, Product / Manufacturing Quality or a related role within the medical device industry.
• Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU Medical Device Regulation 2017/745 (MDR).
• Working knowledge of international standards and regulations applicable to medical devices and combination products.
• Familiarity with Geometric Dimensioning and Tolerancing (GD&T) standards and principles.
• Experience in Statistical Process Control’s (SPC), data analysis, and trending.
• Ability to apply practical and technical problem solving to quality system and product improvements.
• Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
• Proven ability to effectively lead cross-functional team meetings
• Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.
• Champions high quality deliverables, innovation, and appropriate risk-based decision making.
• Ability to understand the sensitivities within the Getinge’s environment.
• Excellent project management and interpersonal skills.
• Adaptable to changes in work environment.
• Ability to work in a fast-paced environment.
• The position is hybrid, with 25% travel as needed.

Quality Requirements:  

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• This position is hybrid with up to 3 days in office

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Monday-Friday, 8:30am-5:00pm

$75,280-$94,100 + 4% STIP

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