Quality Engineer

Job Description:

POSITION SUMMARY

The Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products by performing the following duties:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintains process and validation plans.  Writes process and or validation protocols. Plans execute and complete validation activities. 
• 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.
• Any duties or tasks that your Supervisor/Manager assigns.

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.
• Excellent oral and written communication skills to support design change documentation, team leadership, project updates, interaction with all levels within the organization and communication with external thought leaders (internal and external).
• Strong computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook, and Microsoft Project). Able to type 50 WPM.
• Sound understanding of regulatory and compliance documentation processes, review cycles and information repositories (meeting minutes, templates, charter documentation etc.).
• Strong interpersonal skills that create followership and motivate team members.
• Driven and motivated individual with demonstrated critical thinking and analytical skills.
• Unquestionably high ethical standards and attention to reputational and compliance risks.
• Organized thinker that can prioritize tasks in real time and exercise judgment in high-paced environment.

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 quiet in office spaces but moderate to loud in manufacturing areas.
• 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 10 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.

Job Requirements:

REQUIRED:

• Bachelor's degree (B. S.) in Engineering or a related field from a four-year college or university.
• 2+ years of QE experience in any regulated industry (Medical devices, Pharma, healthcare preferred)

PREFERRED SKILLS:

• Adaptable to work with software-based development and automated processes.
• ASQ Certified Quality Engineer or similar certification is a plus    
• 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
• Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner              
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Works effectively within a cross functional team.

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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.

$95,600 - $116,900

Operating Company:

Ormco

Ormco 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.