Job Description:

　　At Metrex, the Quality Engineer is responsible for assuring quality is designed-in to the new products and processes. Applies knowledge of “Good Engineering Practices,” design control principles, and quality engineering techniques to development efforts as a member of one or more cross-functional development team(s). Ensures products are developed in accordance with applicable industry standards, regulatory requirements, and customer requirements. This position is on-site in Romulus, MI.

　　ESSENTIAL DUTIES AND RESPONSIBILITIES

　　Implements process, software, and test method validation policy and procedures.

　　Write protocols, facilitates completion of validation protocol procedures, performs data analysis, and write reports.

　　Maintains Process and Software Validation Master Plans.

　　Participates in product development teams and in design reviews.

　　Conducts root cause and corrective action investigations for quality failures, including those occurring in supplier and internal processes.

　　Improves quality system by evaluation and improvement to inspection and test methods, sampling plans, and process control plans.

　　Completion of the above duties and responsibilities will include the use of Gauge R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, Capability Studies, the determination of Operating Characteristics for Sampling Plans, and general statistical analysis of data.

　　Prepare and conduct training sessions and presentations as required to complete the above duties and responsibilities.

　　Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.

　　Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.

　　Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.

　　Reviews purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.

　　Maintains a working knowledge of government and industry quality assurance codes and standards.

　　Support, and when appropriate lead, CAPA creation and resolution.

　　Oversees supplier management, including Supplier Corrective Action Reports (SCAR), Supplier Files, Supplier Audits, Supplier Validations, and drafting Supplier Quality Agreements.

　　Job Requirements:

　　MINIMUM QUALIFICATIONS:

　　Bachelor’s degree in Engineering or other technical discipline preferred; we will also consider 4 years relevant Quality Engineering experience in lieu of a degree

　　A minimum of 3 years experience in quality assurance or quality systems; medical device or dental industry experience is preferred

　　Experience in Good Manufacturing Practices and Quality Systems Regulations experience required

　　Proficiency in the use of personal computers and computer database software, including Microsoft Office applications (Access, Excel, Word and PowerPoint).

　　Ability to travel domestically up to 10% (supplier visits)

　　PREFERRED QUALIFICATIONS:

　　Experience with Master Control and/or Oracle is a plus

　　Working knowledge of the FDA Drug Regulations, FDA medical device Quality Systems Regulations and international quality system standards is preferred

　　Must be able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, and working individually and with others within and outside his/her function.

　　Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.

　　Must show self-initiative but be comfortable in the role of a team player. Must be able to manage multiple projects and report progress against goals in an objective manner.

　　Experience in lean manufacturing of Medical Devices.

　　Ability to accurately assess quality measurements and manufacturing operational metrics and situations and effectively address root cause and counter measure implementation.

　　Familiarity with various manufacturing process technologies.

　　Proficiency in project leadership and management.

　　Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

　　Ability to speak effectively before groups of customers or employees of organization.

　　Ability to work with mathematical concepts such as probability and statistical inference.

　　Ability to define problems, collect data, establish facts, and draw valid conclusions.

　　To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software.

　　COMPETENCIES

　　Analytical Decision-Making

　　Communication

　　Learning & Development

　　Planning & Organizing

　　Professionalism & Integrity

　　Risk-Taking/Creative Thinking

　　Teamwork & Relationship-Building

　　#LI-RJ1

　　IND123

　　Operating Company:

　　Kerr

　　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 .