Envista
Junior Quality Engineer
United States of America, New Jersey, Mahwah · Junior
Sponsorship not specified$76k-$93kDetected 2 days ago
ComplianceExcelProcess ImprovementERPRecruitingHRFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft Office
About the role
- The Junior Quality Engineer will also participate in cross-functional projects supporting quality and process improvement initiatives.
- The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.
- The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Responsibilities
- Support the development, revision and maintenance of procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance
- Lead and/or support CAPA investigations and related corrective and preventive actions
- Ensure training support and effectiveness for multiple functions throughout the organization
- Partner with functional teams to support maintenance of the QMS training program per regulatory requirements
- Provide support for internal and external audits and inspections
Requirements
- 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
Skills
- 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
- Knowledge of quality systems and regulatory requirements applicable to medical devices (e.g., FDA QMSR/QSR, ISO 13485, MDR) preferred
- Proficiency in Microsoft Office applications; advanced Excel skills preferred
- Experience with ERP, quality management, or learning management systems preferred
- Basic understanding of validation and qualification requirements for equipment, processes, and systems
- Strong communication and collaboration skills with the ability to work effectively in cross-functional teams
- Excellent organizational skills and ability to prioritize work in a fast-paced, regulated environment
- Demonstrated learning agility, initiative, and commitment to continuous improvement
- Target Market
Compensation
- 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.
- 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.
- $76,000 - $92,900
Company info
- Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.
- Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
- 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.
- 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.
- Ensure exceptional service for internal customers
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