Senior Manager Quality Engineering

Senior Manager, Quality Engineering

· Full-time, permanent position

· Pay Rate: Commensurate with experience.

· Hybrid – San Diego, CA

We at Raise are hiring for one of our key clients in the Medical Device industry. After establishing themselves as an industry leader, our client’s team is expanding to meet rising demand.

They’re looking for someone with leadership ability to make an impact at their organization. It’s a great chance to take on new projects, new teams, and make your mark on a growing business. If you’ve got the right mix of skills and industry experience, this could be the perfect role for you.

Our client takes pride in their people. When you join their team, you’ll find a workplace that facilitates challenge, achievement, and growth.

Responsibilities:

· Perform the general management functions inherent to the position.

· Develop, establish, and coordinate Quality policies and procedures to assure that all software products designed, tested, and released by these sites conform to ISO 13485, IEC 62304 and ISO 14971 and corporate policies and guidelines.

· Assure that all sites and processes employed maintain conformance to established Corporate and Regulatory procedures and requirements.

· Provide recommendations on corporate policies and procedures to optimize quality and increase economic efficiencies.

· Maintain cooperative relationships with all departments within the function. The major interaction occurs with Quality and R&D. These relationships include:

· Partner with the R&D staff to develop and maintain development, testing, and release processes to assure compliance with procedures, specifications, standards, and regulatory requirements while maintaining a profitable operation.

· Partner with the R&D staff and others as appropriate to improve software development and release times while continuously improving the quality of the product.

· Partner with the Corporate Regulatory Affairs to assure safety, quality, and regulatory compliance of processes and products.

· Partner with Corporate Quality, R&D and others as required to develop and execute on the Quality Strategic plan

Qualifications:

· Broad management experience across several functional areas or businesses or concentrated knowledge of a particular discipline; considered the organization’s expert within a particular discipline

· Working knowledge of Medical Device Regulations

· Quality compliance, audit, and investigation skills

· Management skills and experience

· Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)

· Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies

· Able to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)

· Proven ability to work closely with Management level issues

Looking for meaningful work? We can help

Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity.

We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.

We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation: