Design Quality Engineer Job
Job Description Job Attributes+
Principle Design Quality Engineering
Reports to: Manager, Design Quality Engineering
The Principal Design Quality Engineering is responsible for leading and managing quality assurance of medical device products and processes. This remote position will manage quality and compliance activities for Cardinal Health which includes diverse medical devices including Electromechanical devices. Design Quality Engineers ensure that product quality and regulatory compliance goals are met for new product development projects and released products.
Provide leadership, mentoring and training to Junior Quality and R&D Engineers on design controls, risk management, verification and validation practices, and statistical methods. In collaboration with cross-functional team members, shall also provide oversight for the satisfactory resolution of any quality or compliance issues related to released products that are currently on the market.
What is the work you will be doing?
1. Quality Lead in providing quality support in design, development and changes to medical device products.
2. Drive successful execution in collaboration with leadership of quality and compliance strategies and annual Quality Goals.
3. Partner with R&D and center-led Quality Operations team to drive excellence in product quality and regulatory compliance. In collaboration with R&D and manufacturing quality, execute design transfers.
4. Represent the Quality function on cross-functional governance boards such as Corrective Action Board, Design Stage Review Board, Management Reviews etc.
5. Coordinate or lead design quality related product complaints investigations.
6. Meet Quality operating goals and objectives.
7. Provide training/guidance on design control, risk management, statistical methods, industry related standards, and regulatory expectations.
8. Ensure compliance to design control and risk management procedures.
9. Interact with FDA or Notified Body inspectors during audits for body of work owned.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1. Support corporate continuous improvement initiatives.
2. Project Management, special projects and initiatives.
3. Other duties as assigned with or without accommodation.
BS in Engineering and 4+ years of progressive quality engineering/management responsibility with at 2+ years in the medical device industry, or equivalent work experience and/or professional qualificationsWorking knowledge of, and auditing experience to, the FDA Quality System Regulation, ISO 13485, IEC60601, and the Medical Device DirectiveKnowledgeable in test methods and standards for the design, verification, and validation of medical device productsExperienced in product risk management to the requirements of ISO 14971Skilled in statistical methods, statistical process control and sampling plansFamiliar with reliability analysis and test methodsASQ Certified Quality Engineer preferredSix Sigma or Lean Certification(s) desiredGood written and oral communication skillsGood interpersonal skillsEffective coaching and mentoring skillsGood decision making skillsBilingual required – Spanish / EnglishA Covid-19 vaccination is required in order to be employed in this position. This includes either:
2 doses of the Moderna or Pfizer vaccine1 dose of the Johnson & Johnson vaccine
ORGANIZATIONAL RELATIONSHIPS/SCOPE:Partners closely with Quality leadersInteracts with all departments and management personnelInteracts with customers, suppliers, regulatory agencies and notified body representatives
The Colorado Department of Labor requires all employers to provide the following information for all positions that could be performed in the state of Colorado
Anticipated salary range: $56,000 - $87,000
Bonus eligible: No
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.