Quality Deputy Manager – Medical Devices and Instrumentation
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.
Typical Benefits Package:
- This is a full-time position. Day shift: 7am -3:30pm. Night Shift: 2:00pm – 10:30pm. Mon – Fri.
- Benefits package available after 3 months: Medical, Dental, Optical, PPTO, 401K
- Salary: Depending on Capabilities and Experience; Equal Opportunity Employer
Qualifications: Education, Experience, Special Skills and Knowledge
Education – High School graduate or equivalent. Technical college degree preferred.
Specialized Skills or Knowledge
- 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.
About the Company: Cygnus, Inc. is a one-stop manufacturer of high quality precision aerospace sheet metal and machined parts expanding to enter the medical device and instruments industry. The Company’s success, based on the “Cygnus Code of Ethics”, has resulted in a long-standing reputation of “Manufacturing Excellence” winning numerous “Supplier of the Year” and Excellence Awards over the past 32 years. Cygnus Inc. has a wide variety of manufacturing capabilities including CNC routers, CNC mills, CNC brakes and CNC waterjet, in addition to penetrant inspection, heat treat, alodine and anodize processing, painting and the assembly of sub assembly structures. Cygnus has 100 employees in its 44,000 sq. ft. facility located in an ideal quality of life Pacific Northwest resort community with scenic hiking, boating, sailing, fishing, hunting, golfing, skiing, and snowmobiling.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) Matching
- Dental Insurance
- Health Insurance
- Paid Time Off
- Vision Insurance
