Quality Systems Specialist
General Summary of Key Responsibilities:
Directly supports ensuring Quality, Regulatory, and ISO related requirements are being followed. Coaches and mentors internal and external customers in ASO Quality system requirements. Leads the company’s Internal Audit, Corrective Action / Preventive Action (CAPA), Risk Management, Deviation, Quality System trending, and Device Master Record systems. Assists with other Quality Systems that may impact the business.
Leadership and Management Responsibilities:
Employee and Team Development:
- Coach and mentor team members to deliver excellence to every internal and external customer.
- Performs training for employees who impact quality or perform work within ASO’s quality system requirements.
- Establish clear measurable goals and objectives by which to determine individual and team results (i.e. converting metrics, results against project timelines, training documentation, attendance records, knowledge of converting roles and responsibilities, personal development goals).
- Solicit ongoing feedback from fellow team members, superiors, and other departments. Provide ongoing coaching and counseling to team members based on the feedback
- Express pride in staff and encourage them to feel good about their accomplishments.
- Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals.
- Coordinate activities of large teams and keep them focused in times of crises.
- Ensure recognition and rewards are managed fairly and consistently in area of responsibility.
- Follows cGMP and routinely makes decisions using cGMP/process knowledge.
- Organize verbal and written ideas clearly and use an appropriate business style.
- Ask questions; encourage input from team members.
- Assess communication style of individual team members and adapt own communication style accordingly.
Policies and Procedures:
- Know and understand company code of ethics policy, supporting and educating employees in regards to the policy as appropriate.
- Responsible for ensuring all employee and company policies and procedures are maintained and enforced within area of responsibility.
- Identify creative ways to reduce cost by streamlining processes and systems (i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems).
- Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value.
- Provide feedback to superiors on cost and cost trends.
- Assists management in the coordination of all inspector activities to meet requirements.
- Position is qualified to train. Assists management in ensuring Inspectors are properly. trained, knowledgeable in their position, and familiar with respective job requirements.
- Responsible for monitoring and maintaining a FDA compliant quality environment.
- Assists with ISO awareness and FDA quality system training of employees.
- Assists with process and product validation studies, reports, and validation efforts.
- Assists with departmental metrics.
- Assists QA Management with special projects.
- Assists with change management tasks and closures.
- Assist with Overall Department metrics and Efficiencies. This include being an active team member and leading Quality Process improvement teams.
- Assist with the company’s Internal Audit program. This includes completing audits, initiating CAPAs, coaching other internal auditors, and assisting with metrics.
- Assist with review and approval of Validation documents, assist with CAPA Actions, specification processing, deviations, and SOPS/Work instructions, as necessary.
- Accomplishes individual projects as assigned across a wide array of quality system areas.
- All employees have the responsibility and authority to report any action that puts any process or product at risk.
- Other duties as assigned.
To perform this job successfully, the individual must be able to perform each essential duty/ key responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
High School diploma or equivalent required. Bachelor degree in Quality or related field preferred.
5+ years of medical device quality experience required.
Skills & Abilities
Must have working knowledge of ISO, medical device, FDA, cGMP requirements. Prior use of ERP and QAEMS systems and Minitab highly preferred. Proficient in Microsoft Office Applications. Must be able to prioritize and organize multi-functions. Must be a problem solver. Must be detail oriented and possess sound communication skills, both written and verbal. Must be able to work a flexible schedule. Must be able to demonstrate a complete understanding of the position job functions and be able to carry out training as required. Visual acuity or corrective vision required for this position, including close vision, distance vision and color vision. Must possess initiative, common sense and analytical/problem-solving characteristics. Able to speak, read and write in English, bilingual (Spanish/English) a plus.