Director Quality Assurance Compliance

Director, Quality Assurance & Compliance

Job Location: Oxnard, CA

Submit inquiries to: careers@intrimed.com

Who We Are: We are engineers and innovators who design, prototype and manufacture components with nano-scale precision to help companies launch medical devices that improve patient care.

Position Description: This position is accountable for the development and implementation of quality management procedures and systems. As such this role is responsible for the all elements of quality monitoring and assurance so as to ensure that all products manufactured and marketed by IntriMed are free from any flaws or errors and are of the highest quality.

Reports to: Sr. Vice President of Operations and Manufacturing

Direct Reports: Documentation Control Group, Quality Control group

Position Responsibilities: The basic responsibilities handled by the Director, Quality Assurance and Compliance, include but are not limited to:

Develop and implement procedures and systems to assure IntriMed’s Quality System complies with all applicable regulatory standards
Develop and implement methods and systems to assure that development as well as production teams receive support in the following areas: statistical analysis, quality planning and inspection processes, root cause analysis
Review and release all shipments
Conduct routine quality audits and hence determine and document any areas that may need improvement.
Establish Inspection and sampling requirements for validation and production release
Continuously review the policies and procedures and implement improvements upon the existing quality standards.
Review and analyze the effectiveness of the modifications made.
Ensure that all procedures within the company conform to health and safety regulations.
Educate all departments regarding the specific requirements of the customer and regulatory requirements.

Basic Qualifications:

Bachelor in Biology, Microbiology, Chemistry and/or Mathematics.
10 years of medical device experience with 5 years of supervisory experience.
5 years of quality management related experience.
Experience with regulatory, third party, and customer audits.
Must demonstrate proven critical thinking, people and team development skills, strategic aptitude, and independent leadership.
Ability to work collaboratively in a team environment with facilities, regulatory agencies, and customers.
Ability to communicate well, both orally and written.
Ability to understand and analyze issues involving device manufacturing, project management, mathematics (including statistics), technical and legal documents.
Ability to understand issues in relation to product manufacturing operations and their impact.
Ability to provide supervision, guidance, effective training and counsel to others.
Ability to effectively organize, coordinate and execute.
Ability to understand food and environmental regulations and their impact on the organization, and our customers.
Ability to help develop and/or execute strategic plans to meet departmental and organizational goals while complying with regulatory and customer requirements.

Desired/Preferred Qualifications:

Masters of Science of Masters of Business.
10 years of medical device experience with 5 years of supervisory experience.
5 years of management of medical documentation control group.
Experience with 510k submissions.
Experience with software based documentation control systems.

Physical Job Requirements:

Able to sit for extended periods in office environment
Able to utilize computer based documentation control system
Travel is estimated to be about 10% for vendor certification and customer visits

Full Time/Part Time: Full time

Exempt/Non-exempt: Non-exempt

Shift: 1st but may have to be present or coordinate resolution of problems that may be initiated from or impacting operations on “off” shifts.

Director, Quality Assurance & Compliance [PDF]

About IntriMed Technologies

IntriMed Technologies designs, manufactures and assembles ultra-precision mechanical components critical to medical device functionality. We draw on more than 23 years of experience helping manufacturers do more with less – providing innovative product and process design, meticulous quality systems, and highly scalable, fully compliant manufacturing capabilities. The result is truly differentiated medical devices produced more cost effectively.

Think “embedded engineering”: leveraging our considerable resources so our customers can better focus theirs.

IntriMed is an Equal Opportunity/Affirmative Action Employer

	Design & Manufacture of Precision Medical Components Contact Us: 805-436-8400