at BioDerm, Inc. in Geneva, Illinois, United States
Job Description
POSITION SUMMARY:
The Quality Assurance Inspector role (1st shift) supports manufacturing quality assurance activities of Argentum Medical. This position tests and inspects products at various stages of production process and maintain quality and reliability of products.
Essential Functions (ACCOUNTABILITIES/RESPONSIBILITIES):
Performs in-process inspection of materials and products during the medical manufacturing process to established, documented procedures. Records results of inspections where necessary and reports any non-conformity to management.
Performs various activities of inspection and compliance on a weekly and monthly basis. Reviews data obtained during quality assurance activities to ensure consistency with company policies and procedures.
Works with management to solve problems identified during quality assurance activities.
Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
Assists technical and administrative workers engaged in quality assurance activities.
Maintains a working knowledge of company quality assurance documents, instructions, and procedures.
Plays an active role on quality management teams within the organization.
Assists in training personnel.
Assists in investigating quality assurance issues, preparing hand written and typed reports.
Assists with customer complaints investigations.
Assists with Non-conforming and CAPA activities.
Monitor good manufacturing processes for compliance.
Qualifications:
Experience
Minimum of 1-year experience in a quality department or 3 years in manufacturing department of a highly regulated industry, preferably Pharmaceutical or Medical Device company.
Must be able to read and understand quality control gages, calipers, tester and rulers.
Solid understanding of a production / manufacturing environment.
Education
Minimum of High School Diploma/GED.
Associates Degree or higher-level degree in technical or scientific discipline preferred.
Certificate in Quality Assurance (CQI / CQT) preferred.
General Skills/Competencies/Specialized Knowledge
Attendance and Punctuality: Is consistently at work and on time; ensures work responsibilities are covered when absent, arrives at meeting and appointments on time and prepared.
Dependability: Follows instructions; responds to management direction; takes responsibilities for own actions; keeps commitments; completes tasks on time or notifies appropriate management.
Problem Solving: Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Dependability: Follows instructions; responds to management direction; takes responsibilities for own actions; keeps commitments; completes tasks on time or notifies appropriate management.
Problem Solving: Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Interpersonal: Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to other's ideas and tries new things.
Oral Communication: Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
Written Communication: Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively; Able to read and interpret written information.
Team Work: Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.
Ethics: Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Organizational Support: Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.
Adaptability: Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Professionalism: Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Safety and Security: Observes safety and security protocols; reports potentially unsafe conditions; uses equipment and materials properly.
Computer Skills - Familiar... For full info follow application link.
