Pr. Quality Engineer

About the role

Cirtec Medical has been a leading outsourcing partner for complex medical devices for over three decades. We specialize in comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our teams prioritize growth, innovation, and collaboration.

Key Responsibilities

• 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 s/inspection methods.
• Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification sing in cooperation with cross-functional engineering teams per project requirements.
• Absorb and 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.
• Administer 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.

Must Have

• A Bachelor’s degree in a STEM engineering discipline
• 10+ years of experience required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes
• 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 QAMust 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.)

Good to have

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

Qualifications

• Must be able to read, write and speak fluent English

Skills

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

Benefits

Cirtec Medical provides a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.