Senior Sustaining Quality Engineer

Apyx Medical•Clearwater, FL

10d

About The Position

The Senior Sustaining Quality Engineer is responsible for ensuring compliance with internal and external requirements for post-market products, their respective manufacturing processes, and the quality programs that support these products. This role supports the sustainment of manufacturing, product reliability, and process repeatability alongside Operations Engineering. The position supports the continuous improvement of manufacturing processes and of the Quality Systems that support production. The Senior Sustaining Quality Engineer ensures that documented practices meet the true interpretation of the Quality Management System standards by overseeing the testing, monitoring, and inspecting processes of the Business. The position is responsible for providing engineering support to operations to ensure consistent application of quality techniques, determining quality improvement parameters, monitoring production quality, the Master Validation Plan, the sterilization validation program, investigation of manufacturing issues & non-conformances, and developing test procedures in support of the Business.

Requirements

Minimum Bachelor (BS) degree in Engineering or relevant Technical/Scientific degree from a 4 year college.
At least 5 years related proven experience in Quality Assurance, Quality Engineering, and/or Manufacturing Engineering.
Experience in requirements analysis, including testable and measurable specifications.
Experience with test methods and standards for the design, verification, and validation of medical device products.
Experience with reliability analysis and test methods and test method validation.
Experience with appropriately assessing validation and change management documentation as the principal advocate for compliance.
Knowledge of FDA 21 CFR Part 820, ISO 13485:2016, MDSAP, and EU MDR (Medical Device Regulations).
Complete understanding and wide application of technical principles, theories, and concepts in the engineering field.
Proficient at problem solving and analytical techniques such as Is/Is Not Matrix, Fish Bone Diagram, Concentration Diagrams, Contradiction Matrix and Design of Experiments (DoE).
Experience with Corrective and Prevent Actions (CAPA) and Root Cause Analysis.
Proficient in use of statistical analysis and associated tools (e.g. Tableau, Minitab, etc.).
Firm understanding of pFMEA and Risk Management processes.
Excellent written and verbal communications skills.
Demonstrates interpersonal and self-management skills.
Strong organizational skills and attention to detail.
Experience with Microsoft Office applications including Excel, Word, Power Point and Outlook.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an expensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
High degree of judgment and integrity required to deal with complex factors not easily evaluated, making decisions based on conclusions for which there is little precedent.

Nice To Haves

Knowledge of medical device sterilization methods preferred.

Responsibilities

Supports Change Management Program coordinating with change management project managers to ensure appropriate assessment of changes and timely execution of project deliverables.
Support efforts to update technical documentation, product specifications, process quality plans, validations, biological evaluations, etc. for post-market products via the Change Management Program in response to internal changes, supply-chain, or external customer or regulatory requirement updates.
Responsible for the released product/process performance conformance to established processes.
Own the Master Validation Plan and ensure the scheduling and timely completion of periodic validation assessments, the execution of validation assessments based on changes, and a comprehensive listing of all validations and verifications is maintained and kept up to date.
Participate in the design and execution of initial validation/verification activities to support production equipment, processes, and test methods as well as subsequent revalidation/reverification where required.
Lead the Sterilization Program and ensure its compliance to applicable standards, including periodic bioburden testing and review, periodic Sterilization method requalification, and Master product assessments.
Regularly monitor the production process to ensure quality; Monitor production to assure processes are being followed; provide inputs on inspection methods & improvements.
Collect relevant data from various related sources and analyze to effectively monitor and ensure quality outputs.
Maintain statistical process controls and develop sampling plans to ensure processes are in-control.
Develop test procedures and test proposed components for product improvements / substitution.
Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
Develop metrics to monitor trends and present data to facilitate quality, risk-based decision making.
Participate in continuous improvement of manufacturing processes and quality programs supporting manufacturing.
Communicate significant issues or developments identified during quality assurance activities and provide recommended improvements.
Utilize project management tools and lead and/or participate in kaizen events to carry out improvements to Operations and Sustaining Quality Assurance.
Participate in corrective and preventive actions (CAPA)-related activities, including CAPA ownership, if appropriate.
Promote a culture of continuous improvement.
Support the Production team with all measurement and testing requirements and data analysis.
Provide expertise in statistical analytical techniques.
Provide fact-based quality analyses.
Use only formally approved procedures, records, documents and specifications known as “Control Documents”.
Use only properly calibrated and maintained equipment.
Immediately bring to attention of the head of the Quality Assurance department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.
Ensure no components, parts, manufacturing materials or products will be released unless they meet all inspection and test criteria.
Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.
Ensure all purchasing documents are completed to Work Instructions.