Senior Supplier Quality Engineer

Position Scope:

The Supplier Quality Engineer (SQE) is responsible for the establishment/maintenance of a supplier quality program that enables realization of a zero-defect philosophy to our patients/customers for supplied material/services.

Strategic Focus Areas:

The SQE will be responsible for the development and control of suppliers and contract manufacturers (CM). The SQE has direct accountability to ensure that all material/services used in the fabrication and release of Anika products meets specification. The SQE will drive continuous improvement for supplier quality processes to increase compliance and efficiency. Additionally, they will collaborate with all functions to understand business/project requirements to execute improvement strategies for supplier quality performance.

Specific Tactical Responsibilities:

• Develop and implement product and/or process controls required to ensure supplied material/service meets all design output requirements and drive business efficiency.
• Provide input to incoming inspection requirements based on supplier assessments and product process controls for controlling risk.
• Actively drive the assessment and improvement of quality system processes associated with supplier development/quality.
• Full engagement and ownership in resolving supplier quality issues.
• Process requests for the onboarding of new suppliers.
• Track, analyze, and report on supplier performance metrics to stakeholders along with recommendations for tactical and strategic improvements.
• Perform/coordinate Supplier audits (Quality System and/or Product Quality based) and follow up on their results.
• Other duties as assigned.

Job Complexity:

The Supplier Quality Engineer works on complex issues requiring analysis and use in-depth evaluation of factors.

Supervisory Responsibilities:

None

Required Qualifications:

• Bachelor’s degree in Engineering or related field or equivalent experience.
• Minimum of 3-5 years of related experience in the medical device, biotech, or pharmaceutical industry.
• Strong understanding of medical device regulations and standards, including QSR (21 CFR Part 820), Quality Management Systems (ISO 13485), and EU MDR (2017/745).
• Lead Auditor Certification preferred. Preferably ISO 13485.
• Versed in application of ISO 14971 with regards to FMEAs, Verification/Validation, and Risk Management.
• Knowledge of statistical techniques with regards to product development, production processes, and inspection plans.
• 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.
• Must be able to communicate appropriately and adequately to all levels of the organization in both individual and group settings.
• Competency in MS office applications.

Desired Experience, Knowledge, and Skills:

• Experience with SAP preferred.
• Experience with MasterControl preferred.
• Project Management (conducting status meetings, project reporting, etc) is a plus.

Travel:

May include up to 20% travel (including US and OUS).

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.