Quality Complaint Specialist

POSITION SUMMARY:

The QA Complaint Specialist role supports the medical device complaint process of Argentum Medical, as well as supporting QA inspectors and Technicians.

ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES):

Performs the medical device complaint process of Argentum Medical which includes:

• Complaint data collection and documentation
• Complaint investigations
• Complaint actions (Risk analysis, NCP, CAPA)
• Regulatory reporting as required
• Trending and reporting of complaints to management
• Assists inspectors in Non-Conforming Product documentation, evaluations and resulting activities.
• As needed, performs and/or trains others in in-process inspection and final inspection of materials and products to established documented procedures. Records the results of inspections where necessary and reports any non-conformity to management.
• Works with management to solve problems identified during quality assurance activities.
• Keeps management team aware of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
• Maintains a working knowledge of company quality assurance documents, instructions, and procedures.
• Participates in quality management and continuous improvement teams within the organization.
• Trains personnel in production and QA activities.
• Performs investigations for quality assurance issues, preparing hand written and typed reports.
• Performs CAPA activities.
• Monitors good manufacturing processes for compliance.

QUALIFICATIONS:

Experience

- Minimum of 1-years' experience in a quality 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.

- Associate's degree or higher-level degree in medical, technical or scientific discipline 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.

- Teamwork: 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 with Microsoft Word, Excel, and Outlook or similar e-mail program.

TRAVEL REQUIREMENTS/WORK ENVIRONMENT AND PHYSICAL DEMANDS:

Travel

- No travel required.

Work Environment and Physical Demands

- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

- Specific vision abilities required by this job include close vision and color vision.

- Lifting and placement of boxes of raw materials and finished goods is required.