Full Job Description

Cygnus is a high quality precision sheet metal and machine parts manufacturing company looking for an experienced Quality Deputy Manager to primarily facilitate Cygnus’s entry into the medical devices and instrumentation industry. The Quality Deputy Manager, in coordination with the Quality Manager, is responsible for the overall development and maintenance of an ISO13485, FDA Regulated (including GMP’S) quality management system. The job involves a high degree of personal interpretation, judgment, and decision making, and requires the employee to interface with co-workers, suppliers, and customers.

Primary Duties and Responsibilities:

Applicant must have experience in the Medical Device and Instrumentations Industry.

Develop, implement, communicate, train, maintain, and audit the company’s quality systems, policies, and procedures.

Review and approve Quality Department procedures to match customer requirements.

Approve changes to inspection and test equipment and methods

Lead the investigation of nonconformance’s charged to the Quality Department

Audit the work of inspectors to verify their effectiveness

Assign department personnel to write and maintain work instructions

Exercise fiscal responsibility through making cost effective purchasing decisions

Plan, prioritize, coordinate, and schedule departmental work flow including: Internal Audits, Purchase Order Approvals, Calibration, Training, Corrective Action System, and Inspections.

Be able to read, understand and learn customer specifications, Cygnus operating procedures, and work order instructions to certify part Quality Inspection and acceptance.

Position requires Specialized Education/Experience/ Skills and/or Knowledge:

Education – High School graduate or equivalent. Technical college degree preferred.

Requires excellent attention to detail and accuracy for medical Industry requirements.

Must have 3 years of experience in medical devices and instrumentation quality management systems and be familiar with ISO 13485; ISO14971; and FDA/CFR 820

Mechanical aptitude and spatial cognizance to understand and utilize mechanical drawings, blueprints, specifications and quality requirements.

This is a full- time day shift position working 6am - 2:30pm or 7am - 3:30pm M-F

Benefits package available after 3 months: Medical, Dental, Optical, PPTO, 401K and life insurance.

Salary: Depending on Capabilities and Experience; Equal Opportunity Employer.