Our Direct Client is looking for a QA Supervisor in New Britain, PA.

This is a Perm full time position with benefits.

Salary $100,000 to $110,000 per year

About Our Client

Our Client has been an ophthalmology instrument-maker and global market leader for 35 years! Every single day their 500 enthusiastic employees ensure that eye surgeons all over the world enjoy the use of innovative ophthalmic devices, instruments, and liquids. Our client uses cutting-edge technology, works closely with innovative surgeons, and thrives to make a difference. Over 11,000 ophthalmologists worldwide use their advanced Ophthalmic surgery unit to take care of their patients to help them see again.

Scope of Job

As QA Supervisor you ensure that Clients products meet specifications and that the Quality Management System remains FDA and ISO13485 compliant. And you will be the driver of continuous improvement.

Primary Responsibilities

• As an individual contributor you will maintain a Quality Management System that is compliant with FDA regulations, driving continuous improvement.
• managing complaint handling and adverse event reporting, and ensuring that processes, including sterilization, stay in a validated state.
• You will also be responsible for ensuring that released products meet specifications and educating, training, and advising the organization on quality and compliance matters.

Qualifications

• Minimum of 5 years of experience in a senior role in Quality Assurance in an FDA regulated environment, preferably in the medical devices industry, and be ready to drive quality assurance activities across a full site.
• Have a solid understanding of ISO13485 and international regulations.
• You are happy to work as an individual contributor.
• Experience in executing and overseeing quality aspects in product development and production, preferably in disposable products, would be highly advantageous.
• We are looking for someone who is open-minded and always looking for improvement opportunities.
• Minimum Bachelor's degree in a relevant field of engineering and a qualification in Quality Assurance, such as six-sigma, lean, or ASQ.

If you are interested, please forward me your resume in MS Word format.

About RCM

RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.

Equal Opportunity Statement

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job, duty, and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.