Senior Quality Engineer

Position Summary:

The Senior Quality Engineer is a dynamic, challenging, and high impact role that reports directly to senior leadership. Integral to all aspects of the business, the Senior Quality Engineer is responsible for deliverables related to both Design Assurance and Manufacturing Operations.

Essential Duties and Responsibilities:

Participates on Product Development and Manufacturing teams

Develops and maintains product requirements, design specifications, and manufacturing specifications

Develops verification and validation protocols and writes reports

Supports design verification and validation testing including biocompatibility, packaging, shelf life, and sterilization

Completes Test Method Validations including protocols and reports

Supports IQ, OQ, and PQ Process Validations

Prepares inspection plans and control plans

Participates in Material Review Board activities and dispositions nonconforming inventory

Prepares Document Changes Requests and supports associated impacts

Maintains detailed records including Lot History Records and Device History Records

Supports audits of the QMS by customers and regulatory bodies

Ensures compliance with ISO 13485 and 21 CFR 820

Leads and/or supports Risk Management activities

Supports the Supplier Management Process including conducting supplier audits

Supports the CAPA process and leads some CAPA efforts

Required Education, Experience, Skills and Knowledge:

Minimum 5 years experience in a Quality Engineering or Manufacturing Engineering role

Medical Device experience required

Manufacturing experience required

Strong understanding of ISO 13485 and 21 CFR 820 and history of maintaining compliance required

Product development experience desired

Single use medical device experience desired

Bachelor’s Degree in Engineering or Technical Field desired

Audit hosting experience desired

Competency in statistical methods and sampling plans

Excellent aptitude and confidence in customer facing communications

Detail oriented, organized, and diligent in record keeping and Good Documentation Practices (GDP)

Willing to learn and grow within the organization

Salary Range:

$86,000 to $111,000 (25th percentile/90th percentile, PayScale data); Bonus eligible depending on achieving company performance targets.

Benefits:

This position will be eligible to enroll in benefits including health, dental and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k). Position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).

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