Senior Supplier Quality Engineer
Location: Bedford, MA
The Senior Supplier Quality Engineer (SQE) is responsible for the establishment and implementation of disciplines/processes that enable realization of a zero-defect philosophy to our patients/customers for supplied material as well as complaints by overseeing and owning the global supplier program.
Strategic Focus Areas:
The Sr. SQE will be responsible for the development and control of suppliers, contract manufacturers (CM) and Anika subsidiaries as applicable. Additionally, they will collaborate with all functions in order to understand business/program requirements and get input in order to charter and execute improvement strategies for supplier quality performance. The Sr. SQE has direct accountability to ensure that all material used in the fabrication and release of medical devices meets specification. The Sr. SQE will exhibit compliance leadership within the organization by adhering to all regulatory/standard/statute requirements.
Specific Tactical Responsibilities:
- Interface directly with suppliers, CM’s and distributors (as applicable) to develop and implement product and/or process controls required so that supplied material meets all design output requirements.
- Interface with Anika subsidiaries to solve suppliers related issues.
- Full engagement and ownership in resolving all supplier quality issues per quality system requirements and use of Supplier Nonconforming Material Reporting and the Supplier Corrective Action Process.
- Maintain suppliers’ compliance (updated certificates on file, perform suppliers’ re-evaluation)
- Activate and deactivation of suppliers as per procedure.
- Develop and sustain processes for incoming inspection requirements to be the logical result/outcome of pFMEA/Control Plan approach for controlling risk
- Ensure that process control tools like FMEA’s and Control Plans are living documents at our suppliers.
- Initiate supplier & quality agreements as per procedural requirements.
- Perform both Quality System and Product Quality supplier audits.
- Documents and follows up on audit results and required actions to be addressed by the supplier.
- Develop, assess & optimize supplier process as needed.
- Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action
- Track, analyze, and report on supplier performance metrics to stakeholders along with recommendations for tactical and strategic improvements
- Actively participate in the assessment and improvement of quality system processes with emphasis on supplier development/quality
- Other duties as assigned
The Senior Supplier Quality Engineer works on complex issues requiring analysis and use in-depth evaluation of factors.
- Bachelor’s degree in Engineering or related field, plus a minimum of 5-8 years of related experience in the medical device, biotech or pharmaceutical industry.
- Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must.
- ISO 13485 Lead Auditor Certification (Active) from accredited organization
- Demonstrated ability to facilitate/write/review/approve FMEA’s, Control Plans, process and product validation protocols and reports, and IQ/OQ/PQ documentation related to supplier quality.
- Problem solving ability, strong analytical skills and diplomacy required
- Strong oral and written communication skills.
- Self-motivated and ability to manage time working on multiple projects simultaneously.
- Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, SAP and MasterControl.
- Must be able to communicate appropriately and adequately to all levels of the organization in both individual and group settings.
Desired Experience, Knowledge, and Skills:
- Well versed in application of FMEA’s, Control Plans, Verification/Validation, Risk Management (ISO 14971), and Statistical Techniques as it applies to product development and development of production processes.
- Project Management (conducting status meetings, project reporting, etc) is a plus.
- Knowledge of nonconformance, CAPA, and other standard compliance systems.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.