QC/QA Manager

Occam Design (A Division of Creosalus, Inc.) is an innovative leader in the development and manufacturing of the highest quality Class I & Class II medical devices. As a full-service development firm, Occam Design has an exclusive focus on medical products and over 30 years of experience developing medical devices, combination products and consumer healthcare products. Our capabilities and expertise, coupled with a passion for the work we do, results in on-time and on-budget delivery for our clients.

Our expert engineers, technicians and machinists, coupled with comprehensive manufacturing capabilities, provide innovative and reliable solutions to the most challenging applications. With a world of experience, spread over more than 55 patents and over $3 billion in marketplace sales, clients can trust their product’s design, prototyping, manufacturing and rollout to the team at Occam Design.

We are currently recruiting for an QC/QA Manager who will be responsible for maintenance and continuous improvement of the quality management system.

Job Duties & Responsibilities

Duties & Responsibilities:

* oversee internal and external auditing requirements

* quality system improvement

* schedules and prepares management review

* primary contact for notified body and client audits

* update and generate procedures

* document control,

* acceptance activities

* record maintenance and retention

* equipment calibrations

* use of valid statistical techniques

* customer communication

* other duties as assigned.

Job Requirements & Qualifications

Education and Experience:

* Four-year technical degree or equivalent combination of education, training, and experience

* 5-year minimum medical device or pharmaceutical experience.

* 3-year minimum supporting or directing ISO 13485 compliant quality management system 3-year minimum as QC or QA supervisor or manager

* 2-year minim experience managing direct reports

* Knowledge of regulatory requirements and processes, labeling requirements, technical files and CE marking requirements, supplier management, knowledge of ISO and ASTM test methods and standards

* Other skills - Supervisory and related people skills, auditing, inspection, statistical techniques and data analysis, technical writing, risk analysis and FMEA, corrective and preventive action including problem solving and root cause analysis, quality system plans, project planning and quoting, test method development and validation including GR&R, sampling plans, intermediate to advanced MS office skills Fluent knowledge of CFRs and 14971, 60601, 62304, 62366, UDI standards and guidelines.

Job Type: Full-time

Pay: $90,000.00 - $120,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday
• Overtime
• Weekend availability

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Louisville, KY 40204: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO13485 compliant quality management: 3 years (Preferred)

Work Location: One location