- Develops and implements quality plans, validation strategies, and design controls for New Product Development and existing products.
- Implements design control processes, including design verification and validation activities, to ensure the product meets regulatory and user requirements.
- Conducts risk management activities, including risk analysis, mitigation, and reporting according to ISO 14971 and other applicable regulatory requirements.
- Conducts root cause analysis for product issues and develops corrective and preventive actions to enhance product quality and safety.
- Writes, executes, and reviews validation protocols and reports (IQ, OQ, PQ).
- Collaborates with suppliers to identify quality improvements or resolve issues.
- Supports ongoing Global Regulatory Compliance relating to regulatory audits and submissions according to ISO 13485, EU MDR, FDA etc. requirements.
- Support CAPA and Nonconformance investigations and corrective actions to resolve product and/or process issues.
- Participates in continuous improvement activities under the Envista Business System (EBS) and supports the implementation of actions. Implements EBS tools into department activities and standard work.
- Travels up to 10% to local sites.
- Bachelor's Degree in engineering or related field required
- Minimum of three (3) years of relevant work experience required; preferably in the medical device industry.
- Quality engineering experience using quality tools and methodologies required.
- Knowledge of FDA, ISO 13485, EU MDR, and GMP regulatory requirements.
- Certified Quality Engineer (CQE) preferred.
- Strong verbal and technical writing skills in English to effectively communicate across all levels.
- Strong data analytical skills and ability to identify trends and provide recommendations to improve results required.
- Good time management and problem-solving skills required.
- Effective project coordination and prioritization skills are required.
- Good interpersonal skills and ability to build and maintain good rapport and handle situations with confidence, tact, and resourcefulness required.
- Ability to quickly learn computer business systems and software required.
- Intermediate with Microsoft Office Suite including Word, Excel, and Outlook preferred.
- Ability to adapt to changing priorities in a fast-paced environment required.
- Constantly sits.
- Frequently uses hands and fingers.
- Occasionally walks and stands.
- Occasionally bends and stoops.
- Occasionally reaches up/down with arms.
- Occasionally lifts and/or moves up to 5 lbs.
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Design Assurance Engineer - Orange, United States - enVista
Description
Job Description:The Design Assurance Engineer is responsible for developing and maintaining test methods, validations, and verification activities for new product development, sustaining, and quality system compliance activities for dental consumables.
Note: This role will be based in Orange, CA. The position will eventually transfer to our state-of-the-art facility in Pomona, CA in 2025 and will continue to be a hybrid role.
Essential Duties and Responsibilities:
Job Requirements:
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to function in a fast-paced environment, where priorities may change rapidly. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Minimum Qualifications:
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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.
$80,000 - $88,200
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:
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.
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