Regulatory Affairs & Quality Manager

Job Type:

Full-time, Salary Monday through Friday 8am -5pm Work location: On site

Supervisory Responsibilities:

Oversee the daily workflow, scheduling, assignments, training, and projects of the quality department and its employees.

Responsibilities:

Responsible for ensuring production volumes, efficiency, and quality standards are met continuously and consistently. Collaborate with other appropriate management staff to prepare and implement a strategic action plan and cost estimates of materials, time, labor, and other resources required to complete projects. Ensures compliance with codes, guidelines, best practices, and policies. Collaborate with fellow departments to identify and troubleshoot problems. Act as regulatory representative and maintain FDA establishment registration. Develop, maintain, and implement QMS manual, procedures, forms, and databases. Maintain and implement QSMR policies, processes, and procedures. Act as ISO representative and maintain ISO certification, training, and records. Manage and maintain clean room certification, testing, monitoring, equipment, and packaging processes. Perform audits. Report key performance metrics and quality objectives. Creates and maintains vendor relationships and contracts. Performs other related duties as assigned.

Required Skills:

Knowledgeable in

ISO 13485.

Knowledgeable in EQMS. Proficient with Microsoft Office Suite or related software as required to complete and maintain records. Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Project planning and management. Good work ethic and positive attitude.

Education and Experience:

Bachelor's degree preferred. At least 2-5 (two to five) years of experience as a manager in a medical product manufacturing and assembly. Valid Driver's License.

Physical Requirements:

Ability to lift 25 pounds and full range of motion. Prolonged periods standing and walking. Must be able to wear facial mask, and gowning equipment including booties, gowns/jackets, gloves, eye protection when applicable, hair net, and facial hair net if/when applicable. Prolonged periods sitting at a desk and working on a computer. Must be able to access and navigate all areas of the facilities.

Benefits:

Health Insurance Dental Insurance Life insurance 401(k) Paid time off Educational Reimbursement Janco, Inc. is an equal opportunity employer. Janco, Inc. does not discriminate in employment with regard to race, color, religion, national origin, citizenship status, ancestry, age, sex (including sexual harassment), sexual orientation, marital status, physical or mental disability, military status or unfavorable discharge from military service or any other characteristic protected by law.