Acara Solutions is seeking a Quality Engineer to join our client on a Full Time Direct Hire opportunity located in Rochester, NY
85-105K Annually Salary
Come join this leading vertically integrated medical device manufacturing platform partner of the world's most recognized and trusted brands in medical devices.
Essential Duties:
- Provide necessary definition, development, and deployment of the company product quality assurance strategy, addressing all phases of product development, utilizing APQP (Advance
- Product Quality Planning) principles, including IQ/OQ/PQ validation process.
- Develops and implements risk management tools to incorporate into control planning strategies.
- Manages the planning and execution of quality assurance strategies as well as product testing efforts, including all associated resources to meet committed delivery dates, in support of new product launch
- Implements control plan elements to maintain product consistency through all phases of manufacturing.
- Develops and implements standards and methods for inspection, testing and evaluation of materials, products, and processes. Will also compile and write manufacturing and inspection instructions/protocols to support this activity
- Develops sampling procedures, designs, and develops forms and instructions for recording, evaluating and reporting quality data.
- Develops/implements programs to evaluate analytical testing, equipment, facilities, manufacturing processes, measurement systems and performance testing.
- May direct quality department employees on processes for measuring, testing and tabulating data
- Will work independently and in a team environment to support the daily function of the manufacturing operation
- Will work with cross functional teams on continuous improvement projects and new program launches to ensure manufacturing process and products are optimized and cost effective
- Problem solving using formal CAPA tools. Simultaneously fulfil responsibilities on multiple programs with multiple customers
Required Skills / Qualifications:
- Basic knowledge and experience with process validation concepts, phases (IQ, OQ, PQ) and applications, including protocol development and summary reporting.
- Strong knowledge of and practical experience using problem solving & root cause analysis tools (e.g., 8D, 5-Why, fishbone, cause and effect, etc.)
- Proficient in measurement system analysis (MSA/GR&R) desired.
- Proficient in Geometric Dimensioning & Tolerancing GD&T ASME Y14.5, and specification reading, desired. Working knowledge of ISO-13485 and FDA cGMP.
- Application of time management tools.
- Advanced knowledge of industry statistics including proficient use of Minitab or similar statistics analysis software
Preferred Skills / Qualifications:
- Proficient in Design of Experiments (DOE) desired.
- Proficient in process failure modes and effects analysis (pFMEA) desired.
- Experience in Plastic Injection Molding desired.
- Experience in medical or pharma manufacturing desired
