at Belcan in Chicago, Illinois, United States
Job Description
Details:
Job Title: Senior Quality Engineer
Pay Rate: $100 / hr
Location: Chicago, IL
Area code 312, 773, 872
Zip Code: 60661
Start Date: Right Away
Keywords: #QualityEngineerJobs #QualityManufacturingJobs
Benefits:
* Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
* On the job training / cross training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.
* Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
* Scheduled performance reviews create opportunities for advancement and pay increases.
* A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.
Job Description:
Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in quality and compliance activities around Software Development Projects.
Responsibilities
* Assist in ensuring quality and regulatory compliance
* Lead, develop, communicate and implement a quality and compliance strategy.
* Development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
* Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools
* Work with engineering teams closely to drive quality excellence of digital medical devices, including design reviews, processes/practices simplification, quality system training, etc.
* Support continuous product and process improvement through detailed failure analysis for non-conformances
* Investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions
* Utilize risk management tools and aids for use by the organization in accordance with documented procedures
* Support design mitigation efforts.
* Develop process mitigation plans and strategies
* Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Education and Experience
* Bachelor's Degree in Engineering, Computer Science or equivalent.
* Minimum 5 years" experience in Quality Assurance / Regulatory Affairs.
* Minimum 3 years" experience in software within a regulated industry.
* Experience with Agile/Lean software development methods.
* Previous project management experience is preferred.
* Experience in a global working environment.
* Experience leading and implementing change.
* Experience performing internal audits and participating in external audits.
* Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485 is preferred
Skills and Knowledge
* Ability to effectively communicate technical information in English
* Strong leadership and communication skills.
* Demonstrated expertise to effectively communicate within all levels of the organization
* Collaboration, negotiation and conflict resolution skills.
* Ability to lead, acknowledge, develop, communicate and implement a strategy under crisis situations to ensure compliance.
* Understanding of product development lifecycles
* Analytical, problem solving and root-cause analysis skills
* Ability to multi-task
* Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience and demonstrated experience interfacing with regulators.
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity.
Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the engineering, IT, and professional fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce... For full info follow application link.
Belcan is an equal opportunity employer. EOE/M/F/D/V
