Senior Sustaining Quality Engineer

SUMMARY: 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. The Senior Sustaining Quality Engineer is responsible for supporting the sustainment of manufacturing, product reliability and process repeatability alongside Operations Engineering. This position supports the continuous improvement of manufacturing processes and of the Quality Systems that support production. The Senior Sustaining Quality Engineer is responsible for ensuring 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties may be assigned from time to time.

Sustaining Engineering

1. Supports Change Management Program coordinating with change management project managers to ensure appropriate assessment of changes and timely execution of project deliverables.

2. 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.

Operations Quality

1. Responsible for the released product/process performance conformance to established processes.

2. Own the Master Validation Plan and ensure:

a) The scheduling and timely completion of periodic validation assessments

b) The execution of validation assessments based on changes

c) A comprehensive listing of all validations and verifications is maintained and keep up to date

3. 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.

4. Lead the Sterilization Program and ensure its compliance to applicable standards

a) Responsible for periodic bioburden testing and review

b) Periodic Sterilization method requalification

c) Master product assessments

5. Regularly monitor the production process to ensure quality; Monitor production to assure processes are being followed; provide inputs on inspection methods & improvements.

6. Collect relevant data from various related sources and analyze to effectively monitor and ensure quality outputs.

7. Maintain statistical process controls and develop sampling plans to ensure processes are in-control.

8. Develop test procedures and test proposed components for product improvements / substitution.

9. Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.

10. Develop metrics to monitor trends and present data to facilitate quality, risk-based decision making.

Process Improvements & Reliability

1. Participate in continuous improvement of manufacturing processes and quality programs supporting manufacturing

a) Communicate significant issues or developments identified during quality assurance activities and provide recommended improvements.

b) Utilize project management tools and lead and/or participate in kaizen events to carry out improvements to Operations and Sustaining Quality Assurance.

c) Participate in corrective and preventive actions (CAPA)-related activities, including CAPA ownership, if appropriate.

d) Promote a culture of continuous improvement.

2. Support the Production team with all measurement and testing requirements and data analysis.

a) Provide expertise in statistical analytical techniques.

b) Provide fact-based quality analyses.

Other duties may be assigned from time to time.

QUALITY ASSURANCE RESPONSIBILITIES: The individual must comply with the following quality system requirements including, but not limited to:

1. Use only formally approved procedures, records, documents and specifications known as “Control Documents” (e.g., device history records, data collection forms, drawings, procedures, and specifications).

2. Use only properly calibrated and maintained equipment.

3. 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.

4. Ensure no components, parts, manufacturing materials or products will be released unless they meet all inspection and test criteria.

5. Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.

6. Ensure all purchasing documents are completed to Work Instructions.

SUPERVISORY RESPONSIBILITIES: The Senior Sustaining Quality Engineer will have no direct reports.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience

• 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).

Technical Knowledge & Skills

• 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.
• Knowledge of medical device sterilization methods preferred.

Critical Competencies

• Communication Ability: Ability to develop and articulate an effective flow of ideas and information that generates understanding and creates a climate in which others are informed and want to participate. Communicates complex concepts into everyday language.
• 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.
• Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure. Challenges the status quo. Takes stands to resolve important issues. Energized by tough challenges. Is comfortable with change.
• Analyzing & Problem Solving Skills: Use an analytical approach; evaluate a situation from varying perspectives to create well-reasoned solutions. Uses rigor and logic to solve difficult problems, provides honest analysis and looks beyond the obvious. Is able to offer options with a clear evaluation of the risk. Demonstrates continuous learning and looks for opportunities to create process improvements. o Organizational Agility: Able to foster excellent relationships and credibility quickly at all levels of the organization. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives. Can see and understand what drives policies, practices, and procedures.
• Customer & Patient Focus: This individual needs to understand company's customers and competition to maximize opportunities and advantages, and search for ways to leverage the company's current position. Advocates for patient safety and health above all else.
• Results Focused: A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results. Is able to drive goal attainment in others with energy and focus.

LANGUAGE SKILLS: Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to personnel of all levels from top management, public groups, and/or boards of directors to introductory level employees.

MATHEMATICAL SKILLS: Ability to adapt advances mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis or variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY: 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.

PHYSICAL DEMANDS: The physical demands described here are 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. While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel and talk and hear. The employee frequently is required to stand, walk, sit, and reach with hands and arms. The employee is occasionally required to climb or balance and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and risk of electric shock. The noise level in the work environment is usually moderate.