MPI does not discriminate on the basis of race, color, religion,
sex, sexual orientation, gender identity or expression, national
origin, age, disability, veteran status, marital status, or based
on an individual's status in any group or class protected by
applicable federal, state or local law. MPI encourages applications
from minorities, women, the disabled, protected veterans and all
other qualified applicants.
* Develops, establishes and maintains quality assurance
programs, policies, processes, procedures and controls ensuring
that performance and quality of products conform to established
company, international (ISO), and governmental regulatory standards
and agency guidelines, and to ensure customer satisfaction.
* Act as the Quality Systems Management Representative for the
* Maintain compliance and effectiveness to Quality Management
* Represents the business/site to outside customer audits.
Facilitates (with the VP of Quality/RA) any regulatory audits.
* Provides expertise and guidance in interpreting governmental
regulations, agency guidelines and internal policies to assure
compliance, and then assist the organization in driving
* Develops and directs quality programs involving methods,
devices and controls.
* Maintains quality through internal and external inspection of
raw materials and finished items purchased and production
operations and processes.
* Determines and establishes assigned Quality organizational
structure and supervisory relationships. Coaches, develops and
mentors Quality employees.
* Collaborates with cross-functional colleagues to ensure
achievement of standards and regulations
* Bachelor's degree
* 5+ years in quality or engineering
* Experience in managing teams
* Regulatory experience in the medical device space
* Working knowledge of 21 CFR
* Working knowledge of ISO 13485
Our client is a global medical device manufacturer and
distributor that specializes in precision machining and quality.
They seek a Quality Manager to oversee quality production before
their devices are shipped out directly to medical facilities.
* Base salary between 110k and 130k (depending on
* 10% bonus paid out annually
* 4% 401k match
* Tuition reimbursement
* 80 hours PTO per year plus 10 holidays