Easter Seals Jobs

Job Description:

PURPOSE

The Junior Quality Engineer is responsible for the support of daily activities to maintain the quality management system, including supporting incoming inspection, calibration process, training, complaint handling, supplier quality, etc., and ensure quality standards, processes, and procedures are in compliance. The Junior Quality Engineer will also manage projects directly with cross-functional teams to support process improvements. The Junior Quality Engineer also helps to ensure Nobel Biocare’s continued regulatory compliance in accordance with the FDA CFR 820, ISO 13485:2016 and MDSAP (Medical Device Single Audit Program) and the Medical Device Regulations in the EU (MDR)

ACCOUNTABILITIES

• Oversee/ensure execeptional service for internal customers

• Follow all procedures (SOPs) and documentation related to the Quality Management System to ensure compliance to all standards

• Develop and maintain procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance

• Assist in the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, product performance, etc.

• Address and investigate customer complaints according to the medical device regulations; FSA 21 CFR Part 820 and ISO 1348:2016, leading to process/product improvements

• Assist in implementing process improvements by using problem solving techniques, such as Problem Solving Process (PSP), Variation Reduction (VRK) and continuous improvement techniques such as Value Steam Mapping )VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma

• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)

• Lead and/or support CAPA investigations and related corrective and preventative actions

• Ensure training support and effectiveness for multiple functions throughout the organization

• Work with Mahwah Leadership Team to ensure the Quality Management System training program is maintained as per regulatory requirements

• Assist in the reporting of effectiveness of the Quality Management System

• Provide support for internal and external audits and inspections

• Assist in ensuring department goals and objectives are reached

• Report the status of the Quality Management System and other related issues on a regular basis to the Sr. QA Engineer and/or Site Quality Manager

• Other duties as assigned by the Site Quality Manager

Job Requirements:

KNOWLEDGE, SKILLS & EXPERIENCE

Critical Knowledge and Qualifications: (what the role holder must know; including any required general or professional qualifications/education)

• Bachelor’s degree in Engineering or related field, or equivalent combined education and experience

• Minimum 1 year of experience as a Quality Engineer, or equivalent experience working with Quality Management Systems or with process/product improvements in a manufacturing environment

Critical Skills/technical know-how: (what the role holder must be able to do)

• Strong Computer skills (SAP, Microsoft Suite)

• Strong focus on collaboration and team work

• Strong communication skills (Writing, Reading, Spoken) required

• Excellent planning and organizational skills

• Ability to adapt to change, agility

• Working knowledge of FDA CFR 820, ISO 13485:2016, GMP, MDR preferred

Critical Experience:

• Prior work experience in a regulated medical device or pharmaceutical environment preferred

• Prior experience participating in regulatory audits a plus

• Prior experience managing complex data sets or statistical tools a plus

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.

$66,800 - $74,000

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 .