Job Description:

　　ABOUT OSTEOGENICS

　　Headquartered in Lubbock, Texas, Osteogenics Biomedical is a leader in the development of innovative dental bone grafting products serving periodontists, oral & maxillofacial surgeons, and clinicians involved in regenerative and implant dentistry throughout the world. Osteogenics offers a complete line of bone grafting products including: enCore® combination and mineralized allografts, Zcore™ porcine xenograft, Cytoplast™ PTFE membranes, Cytoplast™ RTM collagen membranes, Vitala™ porcine pericardium collagen membranes, Zmatrix™ porcine peritoneum collagen membranes, Cytoplast™ PTFE suture, NovaBone® synthetic putty, the Pro-fix™ Precision Fixation System, and Resorba® dental sutures. Osteogenics was acquired by Envista on July 5, 2022 under the Nobel Biocare division.

　　ABOUT ENVISTA

　　Envista is a global family of more than 30 trusted dental brands, including Nobel Biocare, Ormco, DEXIS, and Kerr 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 a wide range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of 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, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is 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 .

　　JOB SUMMARY :

　　We are currently seeking a senior level, full-time Sr. Quality Engineer to join our team. Quality Engineers will perform various manufacturing and quality support tasks for medical devices, including dental guided tissue regeneration membranes, suture, and bone grafting products.

　　PRIMARY DUTIES & RESPONSIBILITIES :

　　Ensure that the manufacturing processes are in compliance with the established quality standards and regulations

　　Develop and implement process validation procedures and conduct process validation studies

　　Analyze and resolve process-related issues

　　Ensure compliance with regulatory requirements

　　Support the investigating and resolving of customer complaints

　　Conduct root cause analysis

　　Implement corrective and preventative actions (CAPA) to prevent recurrence of identified issues

　　Conduct/support internal audits to ensure that the quality management system is effective and compliant with regulatory requirements.

　　Job Requirements:

　　Bachelor's degree in Engineering or a related field.

　　5+ years of experience in quality, manufacturing or processing improvement.

　　Knowledge of FDA and international medical device regulations around the Manufacturing process (i.e. 21 CFR Part 820, ISO 13485, MDD, CMDR).

　　CAPA or root cause analysis experience.

　　Excellent analytical and problem-solving skills.

　　Must have knowledge of basic computer software applications such as Microsoft Word, Excel, etc.

　　Ability to analyze data using standard statistical techniques.

　　PREFERRED QUALIFICATIONS:

　　Internal auditing experience, a plus.

　　Internal auditing certification (i.e. ASQ Biomedical Auditor, etc.), a plus.

　　Tissue banking experience or CTBS certification ,a plus.

　　#LI-SC1

　　IND123

　　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.

　　$97,100 - $107,500

　　Operating Company:

　　Nobel Biocare

　　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 .