Job Summary
Responsible for supporting the quality engineering operations of receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards. Reporting on the performance of the assigned quality areas. Responsible for maintaining regulatory compliance. Develops quality standards and controls. Develops product and process qualifications/validation protocols/reports for new products and existing manufacturing production lines. Advises company management on quality assurance requirements. Review non-conforming products along with product risk assessment and perform product failure investigations. Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance.
Job Details/Responsibilities
- Participates in the nonconformance process to ensure timely completion of documentation stages.
- Identifies, Reports and Monitors Nonconforming events for the areas of responsibility.
- Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence.
- Interacts with cross-functional teams to resolve quality issues.
- Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
- Develops Quality Instructions and Quality Standards.
- Support in the development, validation, and implementation of Test Methods.
- Suggests, implements, reviews, and approves engineering changes to support product life cycle.
- Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc.
- Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities.
- Applies knowledge in Quality Systems to execute overall project assignments.
- Applies statistical tools to analyze data and identify root cause and problem resolution.
- Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations.
- Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
- Ensures quality system compliance for areas of responsibility.
- Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
- Perform and lead risk assessment exercises in support of validation activities.
- Additionally, this role may also have some or all the following responsibilities (based on specific role within the organization):
- Drive Quality Systems improvement and implementation projects.
- Oversees the Nonconformance process to ensure timely completion of documentation stages and drives monthly meetings.
- Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ)
Job Responsibilities (continued)
Working Conditions/Physical Requirements
Quality Requirements:
- Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
- Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
- Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.
EH&S Requirements:
- Take care of your own health and safety and that of others who may be affected by your actions.
- Work co-operatively to highlight issues affecting Environmental Health and Safety
Knowledge, Skills and Abilities (KSA)
- Works with all levels within the company.
- Ability to organize and conduct multiple, parallel tasks.
- Excellent Written and Verbal Communication
- Understanding of quality system regulations (ISO13485, 21CFR820)
- Ability to interact with all levels within organization.
- Analytical skills for compiling and analyzing data.
- Mechanically inclined
- Knowledge of DOE, SPC, Gage R&R, and sampling plans
- Computer and software skills
- Ability to motivate others and improve efficiency.
- Six Sigma Certification a plus
- ASQ Quality Engineer Certification a plus
- Statistics and data analysis.
Qualifications/ Background Experiences
- Bachelor’s degree in a technical discipline (Mechanical/Biomedical/Electrical engineering), or equivalent, with a minimum of five years of experience in medical device quality assurance.
- Minimum 1-3 years’ experience in Manufacturing Engineering or Quality Engineering with preference having validation experience.
- Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971).
- Understanding of required standards / regulations impacting Medical Devices.
- Leadership ability and organizational skills.
- Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
- Must have experience handling nonconforming events.
- SAP knowledge is a plus.
