Job Description:POSITION SUMMARYThe Quality Engineer II is responsible for ensuring the quality and reliability of industrial processes, materials, and products. This role involves planning and conducting quality assurance activities, maintaining process and validation plans, and participating in design teams to ensure compliance with design control processes. The Quality Engineer applies statistical analysis to evaluate and improve processes, assists with risk management activities, and collaborates with suppliers to address quality issues and improvements. This position requires strong technical writing skills, effective communication, and the ability to work within cross-functional teams. The Quality Engineer also prepares reports, presents technical information, and directs quality assurance activities to support the organization’s quality objectives. The Quality Engineer will report to the Quality Engineering Manager.Job Requirements:ESSENTIAL DUTIES AND RESPONSIBILITIES:
Maintains process and validation plans. Writes process and or validation protocols. Plans executes and completes validation activities (IQ, OQ and PQ).
Participates in design teams as a QA representative to ensure design control process is followed.
Performs quality engineering reviews of design documentation for compliance with stated requirements.
Applies principles of statistical analysis to evaluate the current process and process changes.
Assists with risk management activities including the preparation of the risk management file.
Work with our suppliers to review changes and identify any quality issues or improvements.
Develops new approaches to solve problems identified during quality engineering activities.
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
Prepares and presents technical and program information to team members and management.
Directs technical and administrative workers engaged in quality assurance activities.
Develop an understanding of Envista Business System (EBS) processes and tools and utilize in the execution of projects (i.e. Problem-Solving Process (PSP) and Visual Project Management (VPM)).
Any duties or tasks that your Supervisor/Manager assigns.
JOB REQUIREMENTS:
Bachelor's degree (B. S.) in Engineering or a related field.
2 years of experience in quality engineering within medical device industry.
FDA Quality System Regulation Part 820 and ISO 13485 experience.
ASQ Certified Quality Engineer or similar certification preferred.
SKILLS & QUALIFICATIONS:
Effective interpersonal communication skills and able to interface with cross functional teams.
Strong technical writing skills; able to explain technical terminology in layman’s terms to product development groups, peers and senior management.
Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner.
Adaptable to work with software-based development and automated processes.
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Works effectively within a cross functional team.
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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
Working hours and shifts will vary and are dependent upon the work cycles required by business needs.
The noise level in the work environment is usually moderate to loud.
Due to the nature of product contents, careful handling and compliance to procedure and processes are required.
Ability to stand and/or sit for long periods of time as required by business needs.
Occasionally push, pull, lift and/or bend as required by business needs.
Must be able to lift 25 pounds.
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.
#LI-KC1IND123Target 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.$74,900 - $112,300Operating Company:OrmcoOrmco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.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 .
