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US CO Westminster, United States of America
Onsite
Principal Duties and Responsibilities:
· Serves as the design quality representative on new product development and sustaining engineering teams, ensuring compliance with internal design control processes and external standards and regulations.
· Guides the planning, execution, and documentation of design control activities, ensuring complete and compliant design history files (DHFs).
· Lead Quality related problem solving, including issue investigation, root cause analysis, and data analysis.
· Formulates and refines procedures, specifications, and standards for Highridge Medical products and processes.
· Provides leadership for quality engineering projects including CAPAs and continuous improvement projects.
· Lead risk management activities in accordance with ISO 14971.
· Collaborate effectively/ productively with all departments by developing a team atmosphere.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities):
Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
Facilitates team efforts on quality engineering projects.
Ability to deliver, meet deadlines and have results orientation.
Able to communicate both orally and in written form to multiple levels of the company.
Able to interpret engineering drawings and understand geometric dimensioning and tolerancing (GD&T) principles.
Working understanding of ISO 13485 and ISO 14971
Experience with the MDSAP program and working knowledge of FDA and EU medical device regulations, design assurance, risk analysis techniques, and product testing methods.
Knowledgeable in statistical analysis, including design of experiments, hypotheses testing, and sample plans.
Education/Experience Requirements:
B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) plus 4-6 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
Please visit Highridgemedical.com for additional information.
Highridge Medical is an equal opportunity employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions are considered and evaluated without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender, sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state, and local laws.