Quality Control Lead

Job Summary

Reporting to the Site Quality Manager, the Quality Lead is responsible for ensuring that the organization conforms to regulatory requirements. They will be responsible for examining products and materials for defects or deviations from specifications of the Quality Management System (QMS). This is a highly visible position that will require attention to detail and the ability to communicate effectively with all levels of Team members across the company.

Essential Job Functions

• Determines schedules, priorities, and assigns tasks/resources.
• Train Team members and contractors on company policies; production procedures and forms; and the use of new equipment, as appropriate.
• Develop training plans for new Team members.
• Train new quality inspectors/coordinators.
• Maintain training records of all Team members.
• Maintain Approved Supplier List including questionnaires, agreements, periodic review, and ISO certificates.
• Monitor operations to ensure production standards are met.
• Read product and package specification drawings.
• Responsible for writing and/or assisting in the writing of Quality procedures.
• Helps to perform root cause analysis and corrective actions for quality related issues.
• Generates device history file (batch record file).
• Accepts or rejects finished items.
• Completes non-conformance investigation and creates disposition steps on products and materials that fail to meet specifications.
• Maintain calibrations and preventive maintenance records.
• Maintain Quality binders – pest control, cleaning logs, etc.
• Troubleshooting ERP issues – deleting quality orders.
• Review proofs of artwork prior to literature being printed for production.
• Involved with all aspects of the work order process.
• Change control in MasterControl.
• Create UDI labels for new products and update current labels according to any changes needed.
• Maintains quality service by establishing and enforcing organization standards.
• Perform duties as back-up to the Quality Inspectors/Quality Coordinators.
• Perform duties as back-up to Regulatory Specialist for maintenance of the FDA UDI GUDID system.
• Completes certificates for finished goods per customer requirements.
• Evaluates and inspects customer returns and takes appropriate action.
• Lead or participate in cross-functional meetings as required.
• Order supplies for the Quality Department.
• Support Quality Manager as needed.

Qualifications

• High School diploma and minimum two (2) years of experience working in medical device manufacturing or related field in a team environment.
• One plus year(s) in a Quality Control or Quality Assurance position with a medical device manufacturer or related field.
• Working knowledge of cGMP and cGDP, as well as FDA and ISO standards is a plus.
• Knowledge of testing equipment, statistical methods, and control plans.
• Computer skills including Microsoft Word, Excel, and Powerpoint.
• Knowledge of ERP systems (e.g., Microsoft 365, SAP, etc.).
• Able to work well independently and detailed oriented.
• Strong interpersonal skills with the ability to deal effectively, and respectfully, with a variety of personnel.
• Able to read and interpret documents such as safety rules, standard operating procedures (SOPs), work process aids, company policies, and instruction manuals.
• Able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Able to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Able to compute rate, ratio, and percent.

Supervisory Responsibilities

The Quality Control Lead may have to perform supervisory responsibilities at times, in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing and training Team members, planning, assigning, and directing work.

Physical Requirements

Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping, reaching, lifting, carrying, bending/stooping, kneeling/crawling, climbing, balancing, pushing/pulling, vision requirements - close vision.

Mental Requirements

This position requires the ability to maintain an appropriate work pace, comprehend and follow instructions, exercise logic and reasoning, organize and prioritize, read, compose written communication, communicate verbally, problem solve, count, and compute, and multi-task/re-direct. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.

Other Requirements

The Team member must be trained in all the documents, procedures, software applications and topics listed in the Training Matrix. Additional training requirements may be added as deemed necessary by the supervisor.

Work Environment

The noise level in the work environment is usually quiet to moderate.

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.

Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.