What are the responsibilities and job description for the QA Specialist position at DEXIS?
Job Description
DEXIS is looking for individuals who work their best, help others, and commit to helping us improve our customer lives and celebrate the difference in others.
Who is DEXIS and why should you join the team?
We are the leading manufacturer and distributor of innovative dental imaging equipment, software, and solutions. We offer meaningful work through innovation, diverse opportunities, and career progression.
We Also Offer
Situated on the southern edge of the Lehigh Valley and easily accessible from northern Philadelphia suburbs and the surrounding areas, the Quakertown facility is our North American hub for the design and manufacturing of leading dental imaging devices and software. The facility has a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster strong personal and professional relationships across the organization.
Position Summary
This position will support the Quality, Regulatory, Operations, and Engineering departments by managing all open complaints, escalating Out of Box failures and suspected Adverse Events/MDR’s to the appropriate teams, and providing routine and ad hoc reports in support of reliability improvement projects and other Post Market Surveillance activities.
Essential Duties And Responsibilities
Minimum Qualifications:
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.
$44,000 - $65,900
Operating Company
DEXIS
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.
DEXIS is looking for individuals who work their best, help others, and commit to helping us improve our customer lives and celebrate the difference in others.
Who is DEXIS and why should you join the team?
We are the leading manufacturer and distributor of innovative dental imaging equipment, software, and solutions. We offer meaningful work through innovation, diverse opportunities, and career progression.
We Also Offer
- Competitive Pay and Bonuses.
- PTO, Sick Time and Paid Holidays.
- Tuition Reimbursement
- Competitive leave policies including but not limited to Sick, Jury Duty, Bereavement, Personal, and Parental Leave
- Medical, Dental, and Vision Insurance Benefits effective DAY ONE!!!!
- 401K – with exceptional company match starting DAY ONE!!!!
- Community involvement opportunities & employee appreciation events.
- Newly renovated, state of the art, climate-controlled facility.
- Newly built 1200 sq fitness room.
- Large outdoor patio area with gazebo.
- Gourmet coffee, beverages, snacks, and lunches are available in our café.
- Employee Lounge with pool table, shuffleboard and skeet ball for downtime and employee fun!
- EVC Charges for Electric/Hybrid cars
Situated on the southern edge of the Lehigh Valley and easily accessible from northern Philadelphia suburbs and the surrounding areas, the Quakertown facility is our North American hub for the design and manufacturing of leading dental imaging devices and software. The facility has a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster strong personal and professional relationships across the organization.
Position Summary
This position will support the Quality, Regulatory, Operations, and Engineering departments by managing all open complaints, escalating Out of Box failures and suspected Adverse Events/MDR’s to the appropriate teams, and providing routine and ad hoc reports in support of reliability improvement projects and other Post Market Surveillance activities.
Essential Duties And Responsibilities
- Review and evaluate new complaint notifications to ensure that the correct status was assigned, and information is complete and accurate.
- Coordinate with Technical Support team any changes that may be required because of the evaluation process and/or obtain additional information when needed.
- Filter notifications to escalate awareness and/or additional actions for Out of Box Failures and suspected Adverse Events/MDR’s.
- Manage complaints to ensure that they are closed within process timeframe.
- Utilize established business tools (EBS) to continuously improve processes to further streamline and automate complaint data processing.
- Other duties as assigned.
Minimum Qualifications:
- High school diploma or equivalent plus 3 years of experience working in a quality assurance, medical device and/or manufacturing setting or associate degree in relevant field such as engineering, science, math or operations.
- Must have basic computer skills, including proficiency in Microsoft Office software.
- ERP and document and data control experience.
- Strong interpersonal and communication skills, self-organization, and ability to work with minimum supervision.
- Knowledge of GMP and Quality Systems in a regulated industry (medical device or pharmaceutical area).
- Ability to follow written documented procedures.
- Demonstrated ability to communicate effectively, both verbally and in writing.
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.
$44,000 - $65,900
Operating Company
DEXIS
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.
Salary : $44,000 - $65,900
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