Quality Supervisor - 2nd Shift/Sign On Bonus

Job Description

(for new employees)

This role is for 2nd Shift, M-F 1:30pm- 10pm Onsite

The Quality Supervisor for DHR and Inspection is under the direction of the QA Manager. They will continue maintaining high quality standards of the product inspection and final release process and compliance with regulatory requirements, administer Quality Assurance support to Quality Operations of a complex site and/or demanding compliance profile, and directly supervise Quality inspectors, and Final Release (DHR) employees. Works with Quality Technicians and Quality Engineers for day to day activities supporting all Production Cells and Supplier quality (Operating Companies) at the site has adequate quality support, documentation review, and support projects, process and new product introductions or upgrading of existing processes and products and subsequent qualifications.

- Directs and administers the activities of Inspectors and DHR employees and associated administrators.

- Carries out leading responsibilities in accordance with the organization’s policies and applicable laws including regarding health and safety.

- Evaluates and recommends staffing requirements to ensure maximum utilization of personnel to fulfil department objectives to include cross training.

- Identify individual and team strengths and development needs on an ongoing basis.

- Create and/or validate training curriculum in area of responsibility.

- Establish clear measurable goals and objectives by which to determine individual and team results (i.e. operational metrics, results against project timelines, training documentation, attendance records, knowledge of operational roles and responsibilities, personal development goals).

- Express pride in staff and encourage them to feel good about their accomplishments.

- Perform team member evaluations professionally and on time.

- Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals.

- Ensure recognition and rewards are managed fairly and consistently in area of responsibility.

- Provide communication forum for the exchange of ideas and information with the department.

- Organize verbal and written ideas clearly and use an appropriate business style.

- Ask questions; encourage input from staff.

- Assess communication style of individual team members and adapt own communication style accordingly.

- Ensures that the quality aspects for new processes, products and or upgrading of existing processes and products and subsequent Process qualifications are met.

- Lead and drive inspection strategy related to quality projects such as product implementation, technology implementation and processes improvement/implementation.

- Supports/Initiates investigations for non-conformances.

- Approves specification and process changes per applicable procedures.

- Provides feedback to operations on problems related to quality and/or compliance.

- Supports Operations in evaluation and implementation of actions plans to eliminate root causes of non-conformances.

- Supports internal and external audit programs.

- Assure Quality Management System accomplishment, which is measured through internal and third-party audits trough the internal instructions and procedures of process audit, Quality Gemba Walking and customers’ requirements.

- Promotes the use of Process Excellence tools to enhance analytical thinking and problem- solving techniques.

- Provides support to plant wide initiatives such as implementation of new initiatives safety, environmental and Quality related initiatives.

- Supports and promotes the safety and industrial hygiene objectives of the plant.

- Initiates and maintains interplant communications of quality issues.

- Supports on-going continuing efforts and projects to improve our manufacturing Quality Systems, processes.

- Supports and promotes cost savings opportunities that work toward global objectives in the organization.

- Actively supports other plant functions in the implementation of company programs and projects.

- Reports accidents, incidents, near misses, and hazardous situations in a timely manner and participates in the corrective action process.

- Ensures compliance with company policies and procedures.

- Bachelor’s degree or Equivalent in a Life Science, Engineering, or Physical Science preferred.

- 5+ years of related experience and/or training; or an equivalent combination of education and experience in Medical Device environment.

- Some previous supervisory experience also preferred.

- Knowledge of GxP, GAMP and ISO 13485