Senior Quality Assurance Engineer II

Merit Medical Systems • Pearland, TX

1d

About The Position

Merit Medical is hiring a Senior Quality Assurance Engineer II to support its mission of creating innovative medical devices. The role independently applies standard engineering techniques and works on standard projects, with assistance available for unusual problems. The engineer receives assignment objectives and guidance regarding complex features and possible solutions.

The position is responsible for risk management documentation for assigned product lines or processes, identifying failure modes, facilitating teams, and implementing product or process improvements. It reviews, approves, and generates Engineering Change Notifications (ECNs) related to verification, validation, monitoring, inspection methods, procedures, test protocols, product lines, processes, and production controls. The role also supports supplier quality, nonconformance review and containment, and continued effectiveness of the quality management system. It evaluates whether manufacturing environments have adequate environmental controls, monitoring, personnel, and safety production controls. Participation in design and development may be required.

The role is scheduled for the day shift. The listed physical and environmental demands include lifting up to 50 pounds (local practice may apply), writing, sitting, standing, bending, vision and perceptual tasks, reading, fine motor skills, noise, and chemical vapors. The position is classified as Infectious Control Risk Category II, meaning employment and procedures may require exposure to blood or body fluids.

Eligible Merit employees are offered multiple shifts and hours to choose from, including days, swing, and nights; medical, dental, and other insurance; access to an onsite medical clinic and two onsite cafeterias; an employee garden and gardening classes; three weeks of vacation, one week of sick time, and paid holidays; a 401(k); and a health savings account. Insurance eligibility begins the first of the month after 30 days.

Requirements

• Education and/or experience equivalent to a bachelor's degree in engineering or a related field, with three years of quality engineering experience.
• Strong interpersonal, organizational, verbal communication, and written communication skills, and the ability to work effectively as a team member.
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO 14791, and other medical-device-related standards.
• Ability to work effectively in a team environment through conflict resolution and negotiations.
• Working knowledge of statistical methodologies, quality control, and manufacturing tools, such as applied statistics, lean manufacturing, and Six Sigma.
• Demonstrated computer skills, preferably with spreadsheets, word processing, databases, and other applicable software programs.

Nice To Haves

• Medical device experience or equivalent experience in a regulated industry.
• Experience with SmartCAPA, Oracle, and Crystal Reports.
• Experience handling deviations, investigations, and CAPAs.

Responsibilities

• Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment to make minor adaptations and modifications.
• Work independently on standard projects, with assistance provided for unusual problems.
• Receive instructions on specific assignment objectives, complex features, and possible solutions.
• Maintain risk management documentation for assigned product lines or processes; identify and update failure modes and related product or process improvements by facilitating teams and implementing required changes.
• Review, approve, and generate Engineering Change Notifications (ECNs) to update or create verification, validation, monitoring, inspection methods, procedures, and test protocols for assigned product lines, processes, and production controls.
• Evaluate and participate in supplier selection by monitoring supplier performance, collecting and trending data, and performing supplier quality audits as required.
• Review internal and external nonconformance records to determine disposition, root cause, and the need for corrective and preventive actions.
• Ensure nonconforming product is identified, segregated, and reconciled to prevent unintended use.
• Identify and implement changes needed to maintain the suitability and effectiveness of the quality management system, using quality policy, quality objectives, audit results, and data analysis.
• Evaluate the manufacturing work environment to ensure adequate environmental control and monitoring, sufficient personnel, and safety production controls.
• May participate in design and development activities.
• Perform other related duties and tasks as required.

Benefits

• Medical, dental, and other insurance (eligible the first of the month after 30 days).
• Low-cost onsite medical clinic.
• Two onsite cafeterias.
• Employee garden and gardening classes.
• Three weeks of vacation.
• One week of sick time.
• Paid holidays.
• 401(k).
• Health savings account.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior