Engineer II, Quality - Oldsmar, FL

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.
At Getinge, we exist to make life-saving technology accessible for more people. To meet future expectations and perform at our best, we need Team players, Forward thinkers and Game changers. Located in the beautiful Inverness Business Park, Getinge offers a generous benefit package (including access to health insurance, time off accruals and 401k participation - day of hire), a robust PTO program and fully supports the "work/life balance" philosophy.
This position supports the Getinge site in Oldsmar, FL; Ultra Clean Systems.
As an FDA and ISO-regulated business, an NDA is required. This is a 5-day/week, on-site position.
Job Overview
The Engineer II, Quality provides technical support to internal teams (e.g. engineering, R&D, production) for the quality assurance function.
Job Responsibilities and Essential Duties
• Ensure Quality Systems is run by current regulation 21 CFR 820 and ISO 13485
• Work within Quality to assist in maintaining cGMP compliance for products manufactured, packaged, tested and released
• Work with R & D on new product launches and commercial projects and ensure they are in line with cGMP requirements
• Write and review investigations, CAPAs, NCs, SCARs, Change Notices, and any additional QA documentation functions necessary to run the business.
• Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
• Provide support to production for WIP on the manufacturing floor.
• Support Quality Management during audits and inspections.
• Strengthen quality awareness, throughout the organization, support technical services, and process improvements.
• Ensure that proper document control is handled for facility.
• Review protocols and reports as needed ensuring proper compliance to regulations.
• Support new product development activities through understanding and utilizing the New Product Development Systems. Key activities include quality strategy development, quality planning tools (FMEAs, Quality
Plans, Validation Plans, etc.) and qualification/validation strategy development & execution.
• Chair and/or participate in MRB (Material Review Board) meetings.
• Evaluate new product designs through test protocols and data analysis
• Engage in associated manufacturing/quality process improvement/development support and perform/participate in qualifications/validation activities. Monitor progress using operational metrics and appropriate
trending.
• Identify and assess new opportunities for improvements to work processes, product, and/or services.
• Coordinate technical activities regarding verifications and validations: including protocol development, synchronization of interdepartmental activities, data evaluation, report writing, and presentations to
management.
• Review and provide recommendations regarding product/process qualification/validation and other change control related (CCRs) documentation prior to department management final approval.
• Communicate, interact, and coordinate quality improvement efforts with Production, QA, R&D, and training support to Production, Engineering and R & D.
Required Knowledge, Skills and Abilities
• Must have familiarity with statistical analysis, the ability to analyze and solve problems, and the ability to communicate effectively across departments
• Must demonstrate effective time management and project management skills
• Proficiency with Microsoft Office Products such as Excel and Word or equivalent software applications is preferred. Intermediate computer skills are ideal.
Minimum Requirements
• A Bachelor's degree in Engineering, Science or related fields or equivalent experience is required.
• One to three years of experience in quality assurance, quality engineering or related function is required or MS and at least one year of experience.
• Experience working in the medical device industry strongly preferred.
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
• Responsible for understanding and conforming to the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the
effects on the environment.
• Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
• Responsible for understanding and conforming to the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
• May work extended hours during peak business cycles.
• Must wear appropriate PPE as required per job. Hearing necessary to receive and reply to outside contacts and employees.
• Ability to speak clearly in order to communicate with customers, vendors and employees in person.
• Must be willing to work in both sitting and standing positions for long periods of time, up to 8 hours per shift. Some bending, stooping, reaching and lifting (up to 35 pounds) is required on occasion.
• Willingness to frequently move to various locations within building.
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.
Salary: $70,750 - 88,400
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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.