The posting
The Sr. Manager Quality Engineering is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Quality Engineering function serves as the main quality contact and is a key member of the cross-functional development and sustaining teams. The role serves as the key resource for ensuring compliance to applicable regulatory requirements and quality management system processes.
Key Duties and Responsibilities:
- Foster and sustain a culture of quality that prioritizes patient safety, product reliability, and regulatory compliance. Partner with cross-functional teams to ensure quality is embedded in all aspects of product development and manufacturing, enabling our customers to confidently care for the patients who depend on our products.
- Supports and provides direction to product development teams for the required quality deliverables. Manage quality resource allocation and workload to support assigned projects.
- Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements. Shows focus toward continuous improvement.
- Review, assess, and approve product design documentation to ensure compliance throughout product development cycle. Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
- Write, review, and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed.
- Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Act as a mentor for employees. Be the first level resource for employees and encourage continuous improvement.
- Ensure application of the risk management process throughout all activities with a focus on clinician and patient safety.
- Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.
- Support sustaining activities such as complaint investigation and complaint trending. Monitor and analyze manufacturing and service trends. Able to perform data mining, analyze data and create trend reports.
- Investigates process and product issues identified through complaints and trend analysis of other conformance data. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.
- Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators.
- Support internal audits.
- Provide support for audit preparation activities. Provide oversight and guidance for back-room activities.
Minimum Requirements
- B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 8+ years of medical device experience (or equivalent work experience)
- Travel Requirements (including international): 0-15%
- Minimum of 2 years of supervisory experience.
Preferred Requirements
- Deep understanding of new product development, design controls, risk management, supplier management, and compliance to applicable regulatory requirements for medical device manufacturing.
- Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
- Design for Six Sigma training is desired along with knowledge of statistical methodologies.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.
