Quality Assurance Inspector

Envista Holdings Corporation; United States; On-site; USD 32,000 - 36,000; Full time

Job summary

Envista Holdings Corporation seeks a Quality Assurance Inspector I to perform incoming, in-process, and finished device inspections, ensuring compliance with established specifications. You will document results, use eQMS, and analyze data to support continuous improvement.

Ideally, you have a high school diploma with technical training or quality inspection experience and familiarity with ERP systems and quality records. Collaborative cross-functional work and adherence to GDP are essential.

Qualifications

• High school diploma or equivalent required.
• Experience in Medical Device, Pharmaceutical, or related quality environment preferred.
• Able to read and interpret documents in English.

Responsibilities

• Perform incoming inspection of materials against specs to determine acceptance.
• Document inspection results and quality records per GDP and quality system.
• Identify nonconforming materials and support MRB activities.
• Use eQMS and other systems to document results and nonconformances.
• Analyze inspection data to support investigations and improvement.
• Collaborate with cross-functional teams to resolve quality issues.
• Follow SOPs and quality system requirements.

Skills

Attention to detail

Communication skills

Independent and collaborative

Quality inspection experience

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

ERP (Oracle/SAP)

eQMS

Calipers & gauges

Job description

Position Summary

The Quality Assurance Inspector I is responsible for performing incoming, in-process, and finished device inspections to ensure compliance with established specifications. The position supports quality system activities through the use of electronic quality management systems (eQMS), accurate documentation of inspection results, and collection and analysis of quality data.

Essential Duties and Responsibilities

• Perform incoming inspection of raw materials, components, and supplier-provided products against approved specifications, drawings, inspection plans, and acceptance criteria to determine material acceptance or rejection.


• Document inspection results and quality records in accordance with Good Documentation Practices (GDP) and applicable quality system requirements.


• Identify nonconforming materials and initiate or support Material Review Board (MRB) activities for review and disposition.


• Utilize electronic Quality Management Systems (eQMS) and other electronic systems to document inspection results, nonconformances, and quality records.


• Compile, maintain, summarize, and analyze inspection and quality data using Microsoft Excel and other electronic systems to support investigations, supplier performance monitoring, and continuous improvement activities.


• Collaborate with cross-functional teams, including Engineering, Manufacturing, Supply Chain, and R&D, to resolve quality issues and support product and process improvements.


• Follow departmental Standard Operating Procedures (SOPs), Work Instructions, and established quality system requirements.

Incidental Duties

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

Job Requirements

Education and Proficiency: High School Diploma or equivalent required; additional technical training or quality inspection experience preferred. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to communicate effectively with groups of employees within the organization. Ability to perform these functions in English.

Preferred Skills

• Experience: One to three years of related experience and/or training, preferably in Medical Device, Pharmaceutical, Manufacturing, Quality, or other technical environment


• Computer Skills: Experience using electronic systems and software, including Microsoft Word and Excel. Ability to enter, maintain, organize, and analyze data using Excel. Experience with ERP systems (e.g., Oracle, SAP) and/or electronic Quality Management Systems (eQMS) is preferred.


• Math Ability: Ability to add, subtract, multiply, and divide using whole numbers, fractions, and decimals. Ability to interpret measurements and inspection data accurately.


• Technical Skills: Experience with inspection techniques and measurement tools (e.g., calipers, gauges, and other inspection equipment) preferred. Ability to read and interpret engineering drawings, specifications, inspection plans, and acceptance criteria. Ability to understand product functionality, assembly methods, test processes, and quality requirements.


• Reasoning Ability: Ability to apply sound judgment and follow detailed written and verbal instructions. Ability to evaluate inspection results, identify nonconformances, and make decisions within established procedures and quality standards.


• Abilities: Strong attention to detail and accuracy; effective verbal and written communication skills; ability to work independently and collaboratively in cross-functional teams; ability to utilize electronic systems to document quality records and support data collection, trending, and continuous improvement activities.

Work Environment

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

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Employee is required to sit at a desk for long periods of time Frequently uses hands and fingers, occasionally reaches up/down with arms Position requires occasional standing and walking Position requires occasional bending and stooping The noise level in the environment is moderate

PPE

Safety glasses required worn by all personnel in production areas or as 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. $23.10 - $26.00 per hour

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.