Senior Quality Engineer job in Mannford, OK
Vacancy has expired
Mannford, OK CorTech LLC
| Job Ref: | 345083 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 55.51/Per Hour |
| Remote: | No |
Location |
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| City: | Mannford, OK |
| Post Code: | 74044 |
| Map: |
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Description |
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CorTech is seeking to hire a Senior Quality Engineer for our client in Mannford, OK! Benefits Available! Weekly Pay! $55.51/Hour Hours M-F 8-5 with 1 hour lunch or long as total hours are 40 per week maximum. 8 hours a day 5 days a week. Must haves: Previous create/execute test method validations, technical writing skills, flexible work week to support timing of validation time availability in a manufacturing environment. BS in Engineering Three to five years? experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry. Client is one of the largest global medical technology companies in the world. Advancing the world of health? is our Purpose, and it?s no small feat. It takes the imagination and passion of all of us?from design and engineering to the manufacturing and marketing of our billions of MedTech products per year?to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you?ll be supported to learn, grow and become your best self. Become a maker of possible with us. Essential / Key Job Responsibilities : EU-MDR Senior Quality Engineer - Validation EU-MDR support of submission documents; supports Quality activities surrounding EU-MDR submission of products through execution of identified remediation. Works with multi-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals. Project Management: Assists with creating strategic plans for EU-MDR elements of remediation. Coordinates with team members, internal and external peers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements. Design to Manufacturing Transfer: Supports product and system updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing as it applies. Test Method Development & Test Method Validation: Leads and creates the development and validation of clinically relevant test methods that adequately challenge product design and related processes. Testing: Leads and creates verification and validation activities for products and processes in support of EU-MDR requirements. Other Responsibilities may include, however are not limited to: Support/lead design and process root cause analysis and support non-conforming product and complaint investigations. Ability to make and present risked based decisions. Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) Leads and creates development of risk assessments and test methods Leads and creates component qualifications, design validation / verification and process validation as applicable. Leads and creates product investigations. Assess product changes against product design when applicable. Supports translation of design inputs into manufacturing control plans Prepare and present project updates and technical discussions Provide support to the regulatory department in writing technical submissions Complies with company procedures and policies, government regulations Other duties and projects, as assigned. Required Qualifications: Knows how products are used and impact the user(s) so that risk can be managed effectively. Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to lead creation of risk management files (e.g. PFMEA). Ability to develop solutions with business impact Advanced statistical and risk assessment techniques Working knowledge and creating abilities for test method (development and validation), equipment qualifications, and validations, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training, review and coordinate test protocols and reports Problem solving ability Ability to generate engineering proposals Oral and written presentation skills Ability to Lead cross functional teams Understanding of regulatory requirements including ISO 13485, ISO 14971. Preferred Qualifications: Quality Engineering Certification (ASQ) or equivalent. Education and/or Experience: BS in Engineering Three to five years? experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry. Physical Demands: The employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. They frequently verbally communicate with other associates, and may reach with hands and arms and stoop, kneel or crouch. Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Client is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. For certain roles at Client , employment is contingent upon the Company?s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with Client Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. A career at Client means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It?s also a place where we help each other be great, we do what?s right, we hold each other accountable, and learn and improve every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of Client while leaving a legacy at the same time. And through the organization?s investment in Client University, you will continually level up your tech skills and expertise. BD04123JD | |
ref: (345083)
1011 days ago
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