This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.
- This position may have direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
- Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
- 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.
- Other duties and responsibilities as assigned.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Required Education & Experience:
- Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
- Minimum of 2 years Leadership/Supervisory-level experience, with decision-making authority/responsibilities.
- Minimum of 7 years’ experience in a regulated manufacturing environment.
Preferred Qualifications & Experience:
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- 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.
Technical Requirements, Skills and Training:
- Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
- Strong verbal and written English language 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
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.