Job Overview This position is responsible for providing support for manufacturing of commercial products through review and approval of Change Controls, CAPAs and Deviations. Support new product development as needed. Participates in customer and regulatory audits as part of the Audit Teamtrack implementation of internal and external audits observations for on time closure. Works closely with Operations, Manufacturing Engineering and Research & Development to ensure manufacturing of effective and high-level product quality, while ensuring implementation of efficient corrective and preventive action plans.

Specific Responsibilities:

Review and approve CAPAs, Change Controls. Manage Internal and External Audit programs and maintain associated tracking logs. Has capability to manage these programs within the Electronic Quality Management system upon implementation. Evaluates and improves the above programs to ensure compliance with regulatory requirements. Performs internal audits as assigned and track implementation of audits observations for on time closure.

• Leads investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions as needed. Performs QA review of new and revised procedures, technical protocols, validations and reports as assigned.
• Participates as assigned in the development of customer requirements and design inputs; works with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified
• Facilitates the Risk Management Process in accordance with the latest version of

ISO 14971

; ensures integration of risk management outputs with design, process and regulatory requirements

• Designs and maintains procedures and systems for process and quality data collection
• Conducts and/or supports process capability evaluations and determines critical process control points and appropriate control limits.
• Support equipment and process validation methods to ensure they are properly validated prior to implementation and critical equipment is periodically re-validated
• Conducts gap analyses of in-house practices versus relevant regulations, standards and industry practices; develops plans and implements corrective actions to ensure continued compliance.
• Act as the SME trainer of other QA personnel.
• Performs other related duties as assigned

Job Complexity:

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions. Requires thorough knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices.

Supervisor Responsibilities:

No direct reports. Has responsibility to oversee diverse teams in the implementation of projects.

Experience, Knowledge and Skills Required:

Bachelor's Degree in engineering or equivalent experience Requires a minimum of 3 years related experience and demonstrated working knowledge of scientific principles in medical device manufacturing Prior experience with review and approval of process change controls, CAPAs, Internal/External Audits. Strong knowledge of statistical process control methods and techniques. Working knowledge and demonstrated application of

ISO 14971

Risk Management for Medical Devices Knowledge of GMP/ISO requirements, specifically current

ISO 13485

Medical Devices. Knowledge of the

FDA 21CFR, EU, TGA

(Australia), ANVISA (Brazil) Working knowledge of cGMPs, QSRs, MDDs, MDR Familiarity with the principles of Design Control Working knowledge of Electronic Quality Management System. Working knowledge of Six Sigma a plus Strong writing and presentation skills

Pay:

$85,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Referral program Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person