Work Location: Danvers, Massachusetts Shift: Department: LS-SC-PEOQE Danvers Mobius Qual Assurance Recruiter: Carolyn Angle Jones
This information is for internals only. Please do not share outside of the organization.
Your Role:
As a Senior Quality Engineer in our Danvers, MA production site, you play a key role in the success of the Quality and Manufacturing organizations. Key responsibilities include:
Serving as a steward for product and process quality, providing expertise for evaluation of change control for Mobius products at Danvers and across sites
Leading and overseeing product quality investigations in conjunction with R&D, Mfg, Validation, and plant engineering, ensuring robust root cause analysis, impact and risk assessment, and corrective action implementation
Leading execution of process improvement activities and quality improvement projects with specific focus on right first-time quality metrics, including reduction in non-conformances, reworks, and customer complaints
Leading execution of Organization Level Agreements - Quality commitments and Quality Improvement Projects and working with stakeholders and project teams to ensure successful implementation
Supporting customer facing improvement projects that incorporate evolving customer and industry requirements and addressing customer product related inquiries
Support product and technology transfer activities to Mobius manufacturing sites in China and France
WeekdayShift: Monday-Friday
Who You Are:
Minimum qualifications:
Bachelor's Degree in Engineering, Applied Engineering, Sciences or Equivalent plus 3 years of relevant and progressive work experience
Preferred Qualifications:
Strong people leadership, project management, and problem-solving skills with a proven track record of prioritization and change management
Basic understanding of material analysis tools and techniques i.e. FTIR, DSC Calorimetry, microscopy, particle counters, and integrity testing by pressure decay
Detailed understanding of equipment and process validation and qualification in a regulated industry including associated toolkits i.e. p/dFMEA, statistical process control, sampling plans
Understanding of investigations, impact assessment workflow in a regulated environment subject to time constraints. An understanding of change control process in a regulated industry
Lean Six Sigma and/or root cause analysis training
Experience with Quality Systems (e.g. Deviation, CAPA, Change Control, Documentation Management)
Proven track record of working collaboratively and communicating successfully in a cross-functional and multi-cultural environment
Demonstrate strong quality knowledge: GMP/GDP, ISO standards
Ability to adapt and thrive in a constantly changing business environment
Proficient in computer skills pertaining to MS Word, MS Excel, MS Powerpoint, MS Teams, MS Sharepoint to support data review, analysis and sharing
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
