Silk Road Medical is hiring a Sr. Quality Engineer, Supplier Management, that will be responsible for all aspects of Silk Road’s Supplier Management Program, including auditing and supplier corrective actions; maintaining supplier records; supplier liaison and representative. In addition, this role will include serving as the Quality Engineering representative on New Product Development projects.
The ideal candidate should be experienced in leading cross-functional projects, especially in a highly regulated and clinical environment. Success will require a creative mindset and an ability to manage projects, timelines, and budgets.
- Maintain and improve current Silk Road Medical (SRM) Supplier Quality Program based on best practices and applicable regulations and standards.
- Perform Supplier Audits commensurate of material/service criticality and track to closure supplier actions.
- Communicate quality concerns with suppliers including issuing of SCAR’s and tracking closure of actions.
- Act as supplier liaison and representative in SRM’s Material Review Board (MRB).
- Maintain supplier records according to SRM Supplier Quality Procedures.
- Determine Supplier Process Validation requirements and support/approve supplier validation efforts using sound Statistical methods.
- Product Development – Provide guidance on ISO & QSR requirements as part of the quality engineering support to new product development projects, lead Risk Management efforts in accordance with ISO 14971, and lead process qualification and validation efforts, including IQ/OQ/PQ protocols and reports.
- Metrics Analysis and Reporting – Track and report on quality and business measurements for New Product Development, Supplier related activities and Complaints.
- Perform/Assist with Root Cause Analysis and action planning for internal NCMR’s and CAPA’s.
- Perform/Contribute to Statistical analysis, including Hypothesis testing, Capability Analysis, DOE, SPC, etc.
- Provide input and support to the SRM Risk Management Program
The Person – Key Skills and Qualifications:
- BS degree in Engineering degree or equivalent work experience
- 5 plus years of experience in supplier management
- Knowledge of risk management principles a plus
- Knowledge of Design Controls a plus
- 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.
- Ability to communicate technical specifications and quality concerns using verbal, written and graphical communication methods.
- Able to manage multiple deadlines and provide timely status updates to manager.
- Able to plan and conduct effective, risk-based supplier audits, including travel logistics and timely completion of audit reports.
- Able to negotiation reasonable actions & deadlines with suppliers regarding corrective actions and effectively motivate suppliers to meet said deadlines.
- Must have Passport and able to travel internationally
- Must be able to present audit findings/quality concerns professionally and represent Silk Road Medical in the highest professional manner.
- Must be able to perform/evaluate basic statistical analysis using excel or Minitab.
What We Offer You:
- A collaborative work environment with colleagues who care about each other and the success of their organization
- A workplace where you are treated fairly, compensated competitively, and can learn and develop your skills
- A chance to join an industry which is saving lives and changing the shape of healthcare
- A very fun and supportive environment in a fast-growing organization where there is never a dull moment