Quality Engineer

Metrex Research, LLC; Kentucky; On-site; USD 79,000 - 97,000; Full time

Job summary

Envista in Kentucky seeks a Quality Engineer to independently lead validation activities and drive quality improvements across new product development, sustaining engineering, and manufacturing.

You will apply DOE, FMEA, and statistical methods, support investigations, supplier quality, and design/process changes while ensuring compliance with regulatory, quality systems, and customer requirements in a regulated medical device context.

Qualifications

• Bachelor's degree in engineering (Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems).
• 2–5 years of quality experience in a regulated industry, preferably medical devices.
• Hands-on experience with validation, design controls, risk management, investigations, CAPA, statistics, and quality system requirements.

Responsibilities

• Lead validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Prepare validation reports and interpret data to identify trends and improvements.
• Ensure compliance with regulatory requirements and quality system standards.
• Lead investigations for nonconformances, CAPAs, and supplier/ manufacturing quality issues; conduct root cause analyses.

Skills

Statistical analysis

DOE

FMEA

CAPA

Quality systems

Education

Bachelor's degree in engineering

Tools

MasterControl

Oracle

eQMS

Job description

Position Summary

Job Description: Position Summary The Quality Engineer independently leads technical quality engineering and validation activities supporting new product development, sustaining engineering, manufacturing, and quality system compliance. The role serves as a Quality representative on cross-functional teams and applies validation, design controls, risk management, statistical methods, and structured problem-solving to ensure products and processes meet applicable regulatory, quality system, and customer requirements.

Essential Duties and Responsibilities

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including software. Prepare comprehensive validation reports and analyze and interpret validation data to identify trends, anomalies, and areas for improvement. Ensure validation activities comply with regulatory requirements and organizational/industry standards. Serve as the Quality Engineering representative for new product development, sustaining engineering, verification and validation, risk management, and design or process changes, including review and approval of applicable technical documentation. Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues, including root cause analysis, corrective action development, and effectiveness assessment. Apply quality engineering and statistical tools, including DOE, FMEA, capability analysis, sampling plans, and trend analysis, to assess risk and improve products, processes, inspection methods, and control strategies. Lead technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses, while routine SCAR administration and supplier monitoring remain within Quality Systems. Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within the role’s areas of responsibility. Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality requirements are appropriately incorporated and maintained throughout the product lifecycle. Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives. Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.

Incidental Duties

The above statements describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned by management, as required.

Job Requirements: Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and function effectively in a fast-paced environment where priorities may change. The requirements below are representative of the knowledge, skill, and ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience

Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field. Typically 2–5 years of quality experience in a regulated industry, preferably in medical devices. Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing. Quality Engineer certification or another relevant professional certification preferred.

Required Skills and Abilities

Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards. Ability to independently interpret and apply regulatory, quality system, technical, and customer requirements and resolve complex quality issues using structured problem-solving. Proficiency in statistical analysis and data interpretation, including practical applications of DOE, FMEA, capability analysis, and sampling methods. Strong technical writing, project leadership, organization, and cross-functional communication skills. Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods. Microsoft Office skills and the ability to quickly learn eQMS, ERP, and other business systems; experience with MasterControl, Oracle, or comparable systems preferred. Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.

Physical Demands

Employee is required to sit at a desk for extended periods and frequently use hands and fingers. Position requires occasional standing, walking, reaching, bending, and stooping. The work environment has a moderate noise level. Safety glasses are required in production areas or as otherwise indicated.

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Target Market Salary Range

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans. For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan $79,200 - $96,800

Operating Company

Orascoptic Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf. Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.