Dexis Senior Quality Engineer (Quakertown, PA)

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:

• 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!

Where are we?

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:

The Senior Quality Engineer is responsible for supporting all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The position will work together with Regulatory, Engineering, Operations, and Purchasing to ensure product quality and compliance requirements are met with on-going production demands. The position will be responsible for the support of the broader organization in continuous quality improvement efforts across the Imaging Business Unit, including identification and driving resolutions for Internal/External as well as supplier quality issues (SCARs), CAPAs, monitoring and reporting internal/external PPM (parts per million), and QA support for new product development programs and risk management processes. The ideal candidate will also be responsible for the leadership of process validations (IQ, OQ and PQ) and Material Review Boards (MRBs), and review/approval of supplier data associated with product and specification changes.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Participate in site daily management and provide support in resolving quality related issues.

• Support Engineering and Operations in efforts to launch quality improvement programs.

• Lead the implementation of internal and external quality improvement activities (PPM).

• Ensure that the company's products comply with the US Food and Drug Administration (FDA), local and state agencies and global health authority and agency regulations.

• Execute process improvements as they relate to QMS compliance with ISO/GMP requirements

• Drive Corrective and Preventive Actions (CAPA) related to product/process improvements.

• Work closely with Technical Support and Sales team to improve customer relationships and customer service.

• Write, execute, and review Process Validation Protocols and Reports (IQ, OQ, PQ).

• Utilize Supplier Corrective Action Request (SCAR) process to improve and sustain supplier quality.

• Perform Internal audits and participate in Supplier and 3rd Party Audits.

• Routinely compile and report quality Key Performance Indicators (KPIs) key quality metrics data to multiple organizational levels.

• Support Risk Assessment (DFMEA, PFMEA) and Engineering Change Order (ECO) processes.

• Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials.

• Serve as lead resource for Production Part Approval Process (PPAP).

• Capability of identifying, communicating, and implementing key priorities with minimal guidance

Job Requirements:

• Bachelor's Degree in Engineering or related fields

• 5+ years of experience in progressive Quality Assurance role, exposure to FDA regulations / ISO 13485 requirements.

• Experience with statistical software packages such as Microsoft Office tools.

PREFERRED QUALIFICATIONS:

• 3-5 years of experience in role requiring Root Cause analysis, Statistical Techniques, Lean Manufacturing, and Six Sigma preferred.

• Experience and working knowledge of electrical medical device manufacturing preferred.

• Experience with SAP helpful, but not required.

• Experience with ISO MDSAP requirements and EU MDD/MDR regulations.

REQUIRED COMPETENCIES:

• Sense of urgency: Action-oriented and able to recognize problems and opportunities.

• Communication: Effectively communicate to all levels within the organization and influence change outside of the local span of control.

• Customer Focus: A drive to discover and meet the needs of customers (either internal or external)

• Results Oriented: A drive to achieve results and goals in the short and long term.

• Adaptable to Change: The ability to adapt in an environment of change, uncertainty, and ambiguity. Can pragmatically make decisions in a timely fashion, especially when there is not a clear path.

• Analytical: Conducts comprehensive review of quality issues and complaints.

• Leadership: Leads projects and drives actions to completion.

• Ability to influence others: Must be able to inform, convince, and persuade others to action on key initiatives.

• Excellent problem solving and presentation skills.

• Ability to determine priorities that are urgent and need attention.

• Ability to influence change all at levels within the organization while embracing Envista' s core values.

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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.

$97,100 - $107,500

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.