CORTLAND - Quality Manager - Medical Devices

Actuant Corporation is a $1.2B diversified industrial company with operations in more than 30 countries. The Actuant businesses are market leaders in branded hydraulic and electrical tools & supplies, umbilical, rope and cable solutions, as well as highly engineered position motion control systems. Actuant business operations are divided into four segments focused on the niche markets we serve: Industrial, Energy, Electrical and Engineered Solutions. Actuant trades on the NYSE under the symbol ATU.

CORTLAND is a global designer, manufacturer and distributor of custom-engineered electro-mechanical cables and umbilicals, and high-performance synthetic ropes. CORTLAND serves a number of diverse markets, including Offshore Oil and Gas, Commercial Diving, Geophysical Survey, Remotely Operated Vehicles, Defense/Aerospace, and Medical.

The Quality Manager will supervise Cortland’s quality systems, specifically ISO 9001 and ISO 13485. Applicants should be well versed in the requirements of both quality systems, but experience dealing with the requirements and issues relating to medical products and ISO 13485 is an absolute necessity. Applicants need to have experience creating and administering quality system and documentation dealing with design control, including the verification and validation phases, and risk management. The Quality Manager will be required to create the protocols, author the procedures and manage the testing required for the IQ/OQ/PQ process for both manufacturing equipment and hand fabrication processes. Experience creating procedures for clean room environments, including authoring and managing specifications dealing with both particles and microbial loading, is highly desirable. This individual will deal directly with Cortland’s medical products manufacturing customers. The Quality Manager will also perform as well as supervise testing of related products.

Requirements:

• Applicants should have a minimum of a bachelor’s degree and 5 years of experience in the field of quality control of medical devices.
• Experience with lean manufacturing concepts is highly desirable.
• Experience writing and performimg protocols for validation activities identified through Quality Plans and FMEA..
• Ability to analyze/evaluate validation data and draw conclusions based on the evaluation.
• Ability to supervise and perform testing of products

If you’re looking for a unique, exciting career with variety and potential for growth, Actuant offers challenges & extraordinary rewards for people on a global scale. Choose opportunity choose Actuant!

Actuant is an Equal Opportunity Employer and does not discriminate against any applicant on the basis of race, color, religion/creed, national origin, gender, or sex, marital status, age, disability, use of a guide dog or service animal, sexual orientation, military/veteran status, or any other status protected by Federal or State law or local ordinance.

Actuant will only employ those who are legally authorized to work. Any offer of employment is conditioned on the successful completion of a background investigation and drug screen.