Sr. Quality Engineer at Tecomet Inc United Kingdom

Bristol, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Apr, 26

Salary

0.0

Posted On

05 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, FDA Regulations, ISO Standards, Statistical Analysis, Six Sigma, Problem Solving, Manufacturing Operations, Blueprint Reading, Metrology, Good Manufacturing Practices, Good Documentation Practices, FMEA, Quality Plans, CAPA, Microsoft Office, Minitab

Industry

Medical Device

Description

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. Equal Opportunity / Affirmative Action Employer / Protected Veterans / Disabilities/Drug Free Workplace Tecomet, Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, gender identity, religion, sexual orientation, national origin, disability, genetic information, pregnancy, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.

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Responsibilities

The Sr. Quality Engineer will ensure compliance with quality engineering standards and customer requirements while supporting manufacturing operations. Responsibilities include maintaining quality systems, facilitating quality programs, and investigating customer complaints.