Qa Specialist - Remote Support

JOB TITLE: QA Specialist- Remote Support

DEPARTMENT: Quality Assurance

REPORTS TO: Quality Assurance Manager

POSITION TYPE: Hourly (non-exempt) Expected to work a minimum of 40 hours a week.

POSITION PURPOSE: This position works on-site in Carlsbad, CA, and is responsible for remotely assisting the Management in White City, OR, ensuring compliance to our ISO 13485 certified Quality Management System (QMS) and applicable FDA and International regulations.

REPRESENTATIVE DUTIES AND RESPONSIBLITIES:

Core duties and responsibilities include the following. Other duties may be assigned.

• Manage the relationship with ISO 13485 Registrar and Notified Bodies. Coordinate, schedule, plan, and respond to audits conducted by the ISO Registrar and future FDA audits.
• Coordinate efforts to maintain European Union IVD/IVDD requirements, and to attain IVDR compliance.
• Schedule, coordinate and conduct internal audits of the QMS.
• Manage the document control system, including medical device records. Write, review and update Quality System documentation including SOPs, instructions, forms, plans and related documentation. Train and evaluate employees in QMS procedures, controls and systems.
• Maintain CAPA Program. Identify and manage CAPAs, perform root cause analysis coordinate with other departments to come up with containment actions and solutions to issues.
• Investigate customer complaints and Quality issues.
• Manage the internal quality audit system.
• Manage the maintenance and calibration of laboratory equipment and quality control materials.
• Participate in risk assessments.
• Collect, analyze and report on quality system data including CAPA, customer complaints, nonconformances, audit outcomes, supplier evaluations, inspections, etc.
• Occasional customer service and technical assistance.
• Integrate Quality requirements in design, development, and manufacturing functions and documentation including process validation (installation, operation, and process qualification);
• Maintain the supplier qualification and management processes, possibly including supplier quality audits at critical suppliers.
• Maintain open communication with all departments and upper management.
• Attendance at monthly all employee Safety Meetings.
• Occassional travel to Oregon required.

SUPERVISORY RESONSIBILITIES:

• None

ESSENTIAL FUNCTIONS, REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Meticulous Attention to detail – Accurate record keeping, and GDP is essential for organization and maintaining a productive level of work output.
• Problem Solving – Identifies and resolves problems/potential problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
• Project Management – Communicates changes and progress; Completes projects on time.
• Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication – Strong GDP skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and honesty ethically; Upholds company’s organizational values.
• Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• 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.
• Quality -– Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Attendance/Punctuality -– Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Initiative -– Volunteers readily; Asks for and offers help when needed.
• Ability to read and interpret documents in an English-dominant environment such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization.

MINIMUM EDUCATION / EXPERIENCE:

• Associates degree required.
• 2 years working experience in Quality Assurance in a manufacturing or laboratory environment required or equivalent combination of education and experience.
• Experience writing Quality System documentation including Procedures, Instructions, Forms, Plans, Protocols and related documents.
• Demonstrated experience with GMP and GDP standards.
• Experience working in a regulated manufacturing environment; ISO 13485, ISO 9001 or FDA- 21CFR/QSR 11 standard quality management systems.
• Experience with European Union IVD/IVDD/IVDR requirements.
• Basic mathematical competency, ability to apply concepts of (up to but limited to) basic algebra.

PREFERRED EDUCATION / EXPERIENCE

• Certified Internal Auditor for ISO 13485 or ISO 9001.