Quality Engineer II
About The Position
The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. He/she will support new product development and design through design verification activity. This individual will support design control activities for new product development efforts. This individual will develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams. He/she will provide leadership in the understanding of medical device regulations to other disciplines. The Quality Engineer II will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Supply Chain, Regulatory, Manufacturing, and Marketing.
Requirements
- A minimum of a Bachelor's degree in a Technical or Scientific discipline is required.
- A minimum of 2 years experience is required.
Nice To Haves
- An advanced degree in a related field is an asset.
- Quality Engineering/Process Excellence/Lean experience is preferred.
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Biomaterial and/or Mechanical product knowledge is preferred.
- Experience with Blueprint reading/literacy including GD&T is preferred.
- Familiarity with inspection methods and techniques is an asset.
- Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.
- Excellent problem solving, decision-making skills and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
Responsibilities
- Support new product development and design through design verification activity.
- Support design control activities for new product development efforts.
- Develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans.
- Conduct audits of new suppliers as part of the project teams.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Supply Chain, Regulatory, Manufacturing, and Marketing.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
