What are the responsibilities and job description for the Quality Engineer position at Grey Search + Strategy?
About the Company
Our client forms lasting partnerships with customers to design, develop, manufacture and bring to market innovative engineered solutions for demanding medical device, biotech and pharmaceutical applications. They act as an extension of customer project teams to help them realize their goals, whether an accelerated time to market, efficient scale-up, a consistent, quality supply, or any combination thereof. Their experienced teams are focused specifically on serving the medical markets and delivering value to customers globally through a strong set of core capabilities.
About the Role
The quality/senior quality engineer is responsible for the development and administration of a quality system compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. You’ll work with internal and external customers supports, quality, and continuous improvement using appropriate tools and project leadership
Responsibilities
QUALITY ENGINEER EXPECTATIONS
- Supports internal audit program as necessary
- Supports customer complaint (CC) and RMA system per procedures; performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close; looks for trends to determine actions to decrease number of CCs
- Maintains non-conforming (NC) system per procedures; performs investigations, participates in MRB (material review board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions and approves to close; looks for trends to decrease number of NCs and provide feedback to management
- Maintains corrective and preventive action (CAPA) system per procedures; initiates and performs root cause analysis; uses statistical and capability analysis to solve problems; implements and verifies CAPAs
- Performs trend analysis of CAPA, NCM, complaint/customer feedback, risk management activities, audits, etc, and presents periodic reports for management review; assesses design and any associated activities for manufacturability
- Adheres to the company’s quality system (QS), writes and approves QS documents
- Authors and executes quality plans for quality management systems and organizational objectives projects
- Support engineering, manufacturing, and inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality
- Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
- Conducts studies including gauge R&Rs to develop inspection methods and test equipment; creates measurement system programs, when necessary
- Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs
- Creates, reviews and approves equipment qualifications, process, cleaning, and software validation, pFMEA and other documentation as necessary
- Participates in customer and ISO audits
SENIOR QUALITY ENGINEER EXPECTATIONS
- Trains company personnel as needed in areas such as use of equipment, inspection methods, statistical methods, processes, and quality system
- Serves as project team leader on small projects; schedules project activities and meets deadlines
- Provides mentorship to other quality engineers and technicians through experiences and education as opportunities arise
- Develops ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement
- Successfully manages multiple high-profile projects simultaneously
Education Experience
QUALITY ENGINEER REQUIRED QUALIFICATIONS
- Four-year degree in quality, engineering or any related field
QUALITY ENGINEER DESIRED QUALIFICATIONS
- 2 years in a manufacturing environment in a technical support role
- ASQ Certified Quality Engineer
- Formal Six Sigma Yellow/Green Belt training
SENIOR QUALITY ENGINEER REQUIRED QUALIFICATIONS
- Four-year degree in quality, engineering or any related field
- 7 years in a regulated manufacturing environment
- Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
SENIOR QUALITY ENGINEER DESIRED QUALIFICATIONS
- Certified Six Sigma Yellow/Green
- ASQ Certified Quality Engineer and/or Auditor
- Class I, II, and/or III medical device manufacturing experience