Quality Engineer

Position Title: Quality Engineer

Job Description
The Quality Engineer is responsible for maintaining and improving the quality of Tactile Medical products and processes and improving supplier management and performance.

Pay Range: $43-51 per hour, depending on experience

Schedule: 8a-5p, Mon-Fri

Location type: Onsite (New Brighton, MN)

Type: Contract role for approx. 6 months with evaluation of extension at 6 months

Responsibilities
* Coordinate the tasks for the electronic Quality Management System (QMS)
* Plan and conduct analysis, inspection, design, testing and/or integration of test methods to assure the quality of assigned products or components
* Develop test methods and participate in the assessment of incoming, in-process and final test/inspection
* Perform root cause investigations and develop corrective action plans for product and process non-conformities
* Develop, monitor, coach and supervise staff, ensuring the development of employees through orientation, various training and feedback
* Coordinate the documentation review, inspection workflow, training, problem solving and calibration for Tactile Medical products and test equipment
* Track and report quality metrics
* Advise on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality
* Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits
* Participate in the non-conformance reporting system, driving timely disposition and closure. Lead and/or participate in MRB meetings. Identify non-conformance trends and develop and administer technical investigation and corrective action plans to resolve recurring quality problems
* Contribute to the development and implementation of product test plans including verification and validation of products and processes
* Serves as liaison to design, procurement and manufacturing engineering
* Participate as a resource in validations applicable to processes and products
* Perform standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records
* Collaborate with Manufacturing, Supply Chain, and Engineering as needed to address supplier quality issues
* Monitor and communicate supplier performance on an ongoing basis to develop improvement plans
* Maintain appropriate supplier evaluation files and records
* Coordinate and performs supplier audits as needed
* Manage supplier corrective action requests to ensure timely completion and effective
* Other duties as assigned

Requirements:
Education & Experience
* 3+ years of experience as a Quality Engineer within the medical device industry
* BA/BS degree in science or another technical field
* Previous experience with CAPA
* Ability to travel up to 15%
* Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) (Preferred)
Knowledge & Skills
* Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
* Demonstrated skills in statistical analysis
* Exceptional computer skills
* Strong analytical and problem-solving skills
* Ability to work in a fast paced, dynamic and growth environment
* Excellent interpersonal skills: ability to articulate verbally and written, review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead or conduct teams and meetings
* Proven ability to work with minimal direction, as well as be resourceful and independent in solving problems and multi-task effectively
* Strong attention to detail
* Ability to supervise a team, providing assessment, training, feedback and guidance

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.