Pr. Quality Engineer

Description

• This position may have direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
• Author and execute Quality Plans for Quality Product Design and Development projects.
• Initiate and/or consult in the development and/or update of Risk Management and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
• Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
• Develop and justify appropriate sampling plans with characterization of test/inspection methods.
• Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Represent Quality Engineering in design and phase reviews throughout the product development process.
• Provide Leadership Engineering Technical Expertise and Guidance for site-level Quality functions.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA's, CCR's and NCMR's.
• Provide statistical data / trending analysis on CAPA, Complaint, NCMR and other quality metrics.
• Support site customer-requested auditing activities (Customer and Regulatory Agencies).
• Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
• Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal, local, and organizational laws/policies.

• A Bachelor's degree in a STEM engineering discipline
• 10+ years of experience required; or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Minimum of 2 years Leadership/Supervisory-level experience, with decision-making authority/responsibilities.
• Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
• Strong verbal and written communication skills.
• Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
• Competency with Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
• "Hands-on" self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA
• Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
• Must be able to read, write and speak fluent English
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.
• Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)

• Quality certification(s) (e.g., ASQ CQT, QCI, etc.)
• Class I, II and/or III Medical Device manufacturing experience