Essential Duties and Responsibilities:
Essential Duties and Responsibilities:
- Write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing processes, inspection procedure and test procedures. Review and approve completed procedures to assure compliance with content and regulatory requirements.
- Support New Supplier Approval process as Quality lead to ensure adherence to local and global work instructions. Support maintenance of the Approved Supplier List.
- Perform Supplier Evaluations by conducting remote performance and desktop reviews.
- Facility, Product-Specific & Quality System audits for compliance to requirements and to verify supplier capabilities and quality. Initiate and manage CAPAs that result from the audits.
- Support DJO Corrective and Preventive Action Process
- Investigate supplier caused product problems, driving root cause identification and corrective actions.
- Manage Supplier Corrective Actions, communicating and coordinating CAPA completion of suppliers.
- Support Internal CAPA Program as required, including by example and not exclusion performing CAPA investigations and improvement implementation, verifying implementation and effectiveness of improvements.
- Support Material Review board (MRB) meetings; review and decide disposition of non-conforming supplied materials
- Support Nonconforming Material investigation and review, maintain Agile NCMR data for supplier related NCMRs.
- Support the Global Supplier Review Board to review supplier quality performance and trends. Develop and present supplier metrics for review and track assignments and action items resulting from SRB meetings. Metrics may include (by way of example and not exclusion):
- Supplier Defective Parts Per Million (DPPM) and Yield trends
- Supplier caused Product complaints, non-conforming material reports and audit non-conformance for Supplier Correction Action Requests (SCARs);
- Supplier Corrective Actions
- Supplier Scorecard trends
- Support and facilitate Supplier Change notices
- Support Supplier Process validation activities.
- Support Certification of process and inspection methods to enable reduced DJO inspection by leveraging certified supplier inspection data and methods.
- Support Cost of Poor Quality Initiative, by developing and executing site projects to reduce the costs associated with poor quality
- Support New Product Development
- Participate in new product status meetings as required - review project plans and give input to QA activities, milestones and procedures related to Supply Chain plans.
- Support Design Transfer activities to ensure the qualification of supplier manufactured parts and components
- Participate in design reviews to ensure adherence to design control requirements, material callouts and standards and procedures.
- Conduct internal audits:
- Conduct interviews, summarize observations, conduct closing meeting with Department Supervisors
- Enter non-compliances into the Agile system and trend software, and follow-up with process owners until CAPA is closed.
- Assist in and support Notified Body Audits, FDA inspections and other 3rd party audits.
- Performs other duties as assigned by Management
To perform the job successfully, an individual should demonstrate the following competencies:
- Analytical - Synthesizes complex or diverse information.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
- Project Management – Manage multiple assignments and projects simultaneously, communicates changes and progress.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification.
- Written Communication - Writes clearly and informatively; Varies writing style to meet needs; Able to read and interpret written information.
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Business Acumen - Understands business implications of decisions.
- Diversity - Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
- Judgment - Exhibits sound and accurate judgment; Includes appropriate people in decision-making process.
- Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree in Science or Engineering and 5 plus years of applicable experience (CQA or RABQSA, CQE or CmfgE certification preferred)
- Requires certification to perform audits. Certification may be obtained through successful completion of an RAB auditor course, successful completion of CQA (Certified Quality Auditor) or on-the-job training by another qualified internal auditor.
- Requires experience necessary to demonstrate the capability to carry out specialized technical/trade/craft procedure. May require regular use of speaking skills to discuss/explain semi-complex information or writing skills to communicated standard matters or procedures.
- Requires experience in biomedical engineering standards and concepts. Preferred knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
- Requires basic knowledge of manufacturing processes (and associated tools, instruments and test equipment) to include inspection, machine shop technology, polish/grind and clean room technology.
- To perform this job successfully, an individual should have knowledge of Microsoft Word, or equivalent word processing software; Excel, or equivalent spreadsheet software. Statistical analysis and data base searches.
Skills and Technical Requirements:
- Competent working knowledge of US and International quality system regulations.
- Proven project management skills; able to complete technical projects with minimal supervision. Strong interpersonal communication and teamwork skill.
- Ability to understand and interpret drawings and data – GD&T knowledge to interpret mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs.
- Ability to read and comprehend simple instructions, short correspondence, and memos.
- Ability to write simple correspondence.
- Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
- Spanish language proficiency a plus.
- Ability to apply common sense understanding to carry out written or oral instructions.
- Ability to deal with problems involving a few concrete variables in standardized situations.
- To perform this job successfully, an individual should have solid skills in Excel, Word, Access, Microsoft Project, Oracle, Agile, and similar applications.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this Job, the employee is regularly required to sit and use hands to finger, handle, or feel.
- The employee is frequently required to talk or hear.
- Employee must occasionally lift and/or move up to 25 lbs.