Sr. Quality Engineer

Orchid Orthopedic Solutions LLC; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Orchid Orthopedic Solutions LLC in Florida is seeking a Senior Quality Engineer to ensure compliance with FDA, ISO and GMP standards while driving continuous improvement. You will interact with teams to resolve quality, cost and schedule issues and lead quality initiatives across manufacturing operations.

The role requires a strong background in quality systems, FMEA/PPAP, and problem-solving methods, with experience in medical device manufacturing and regulatory requirements.

Qualifications

• Bachelor's degree in quality or related field with acceptable experience.
• ASQ CQE or CMQ/QE preferred but not mandatory.
• 4 years' quality experience in medical device manufacturing preferred.
• ISO 13485, FDA 820 knowledge and customer interaction experience preferred.

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Collaborate with manufacturing/ops to resolve quality, cost and schedule issues.
• Prepare FMEA's, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.
• Write and maintain quality related work instructions and procedures.

Skills

Quality systems

Regulations FDA GMP ISO

Blueprint reading

GD&T

Metrology

8D problem solving

Math skills

MS Office

Minitab

Measuring devices

Manufacturing operations

Education

Bachelor's Degree in Quality or related field

ASQ CQE or CMQ/QE preferred

Tools

Minitab

Microsoft Office

Calipers

Job description

Sr. Quality Engineer

Position Summary

The Sr. Quality Engineer will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet's principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

Principle Responsibilities

• Maintaining applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Supporting the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA's, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
• Special projects as assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques.
• Applies statistical and Six Sigma concepts and techniques.
• Works with Internal and External Customers.
• Participates in audits and inspections.
• Writing and maintaining quality related work instructions and procedures.

Qualification Requirements

Credentials/Experience:

• Bachelor's Degree in Quality or related field and/or a combination of education, certifications and experience will be considered

Experience/Educational/Training Preferred:

• ASQ CQE or CMQ/QE preferred
• 4 years' experience in quality within medical device manufacturing industry preferred
• ISO 13485, FDA 820 and customer interaction experience preferred

Knowledge, Skills, and Abilities:

• Manufacturing operations - forging and/or machining.
• Measuring devices.
• Quality Systems.
• Regulations - FDA, GMP and ISO.
• Blueprint reading.
• GD&T.
• Metrology.
• Problem solving and 8D.
• Math skills (algebra, trigonometry) skills.
• Microsoft office (Word, Excel, Outlook, PowerPoint).
• Minitab.

Other Requirements

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10%

Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.