Senior Supplier Quality Engineer
$150k/y-$180k/y
2 days ago
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OnsiteFull-timeMid
Summary
Anika is seeking a Senior Supplier Quality Engineer to join their team in Bedford, MA. The role involves establishing and maintaining a supplier quality program to ensure a zero-defect philosophy for supplied materials and services.
About the Role
As a Senior Supplier Quality Engineer, you will develop and control suppliers and contract manufacturers, ensuring that all materials and services meet specifications. You will drive continuous improvement in supplier quality processes, collaborate with various functions to understand business requirements, and execute strategies for enhancing supplier quality performance. Your responsibilities will include implementing product/process controls, assessing supplier performance, conducting audits, and resolving quality issues.
About You
Required:
- 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).
- 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.
- Competency in MS office applications.
Preferred:
- 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.
- Experience with SAP preferred.
- Experience with MasterControl preferred.
- Project Management experience is a plus.
Benefits
- Discretionary bonus program for all full-time employees.
- Comprehensive healthcare benefits.
- Health savings account.
- 401(k) plan with up to 5% company match and immediate vesting.
- Employee stock purchase plan at a 15% discount.
- Accrued paid time off.
- Additional long-term incentives including stock awards.
Anika
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. We partner with clinicians to understand what they need most to treat their patients and we develop minimally invasive products that restore active living for people around the world. We are committed to leading in high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions. Anika. Restore Active Living.® For more information about Anika, please visit: www.anika.com
Bedford, MA