Quality Assurance Engineer II
2 weeks ago
Position Overview
This role is a Hybrid opportunity at our corporate office.
OBJECTIVE AND SCOPE
The Quality Assurance Engineer II is accountable for various Quality Engineering functions, including data gathering and evaluation, specification assessment, product validation, and design evaluations.
Collaborates with interdisciplinary teams to uphold superior quality, innovative, and compliant medical devices by ensuring adherence to design controls, leading and facilitating product testing, and updating risk management documentation. Additionally, this role involves generating procedural documentation and serving as a resource for relevant standards and requirements.
KEY RESPONSIBILITIES
Employs established protocols and procedures to execute routine tasks.
Possesses familiarity with quality documentation and the capability to draft inspection records, specifications, and various reports. Understands techniques for ensuring data accuracy and integrity.
Conducts investigations into root causes and corrective actions for internal processes, while also supporting similar efforts for suppliers.
Acts as a representative of the Quality Department in supplier enhancement initiatives and product modifications or supplier collaboration programs.
Participates in project and process enhancement teams representing the Quality Department.
Demonstrates knowledge of statistical distributions such as Binomial, Poisson, Normal, and Exponential, applying statistical inference as necessary.
Conducts correlation and regression analyses, experimental design (DOE), and acceptance sampling; interprets Gage R&R studies.
Utilizes statistical software and quality tools for data analysis, including risk assessments, flowcharts, control charts, scatter plots, histograms, and root cause analysis tools such as the 5 Whys, fishbone diagrams, and Is/Is Not exercises.
Incorporates risk management methodologies throughout the product lifecycle.
Maintains cleanliness and organization of the workspace and laboratories.
Demonstrates the ability to work independently as well as collaboratively within a team. Communicates effectively with colleagues and escalates issues to supervisors or managers when necessary.
Adheres to the Code of Business Conduct and all relevant company policies and procedures, as well as local, state, and federal regulations.
Exhibits a willingness to undertake additional departmental responsibilities as required to support compliance efforts.
Additional duties may focus on specific departments or locations as outlined in relevant addenda.
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
The physical demands and environmental characteristics described here represent those encountered by an employee while performing the essential functions of this position.
Must be capable of lifting and/or moving up to 25 lbs.
Must be able to stand for extended periods in a laboratory setting.
EDUCATION
A Bachelor's Degree is required.
EXPERIENCE AND REQUIRED SKILLS
3 to 6 years of relevant experience.
Experience in medical devices and/or pharmaceuticals.
Familiarity with plastics and fluids products.
Knowledge of FDA, Health Canada, and ISO13485 regulations as they pertain to medical devices and pharmaceuticals.
Experience with product shelf-life stability testing.
Understanding of sterilization processes.
Proficient in descriptive and inferential statistics, basic probability concepts, the Central Limit Theorem, and the assumptions and robustness of statistical tests, including the use of Minitab.
Assists in addressing inquiries or complaints from customers, regulatory bodies, or business community members.
Ability to comprehend and apply mathematics at an engineering or scientific level.
Demonstrated analytical and troubleshooting skills to resolve issues related to manufacturing processes and product design.
Strong computer proficiency and presentation capabilities.
Excellent oral and written communication skills.
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