By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
What you will do in this role:
The primary purpose of this role is to be a functional leader within the quality organization who coordinate the activities of and provides daily direction to a team of quality professionals, including any combination of quality engineers and technicians, to ensure that quality requirements, performance goals and improvement objectives for a manufacturing site are achieved. Your primary focus will be on performance management and the growth, development, of your direct reports in support of the QMS.
The Design Assurance Supervisor will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch. In addition, you may lead efforts to identify potential gaps in existing processes and systems and to drive process improvements required to enable your department to execute at a more accurate and efficient level.
You adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA)regulations, Company policies and operating procedures, and other regulatory requirements as required within your location
Build & develop teams:
- You will be supervising, coaching, and directing a team of quality professionals in support of one or more product lines or process areas within a manufacturing site.
- Your leadership style encourages teamwork, cross functional consensus building and ensures accountability within your team and across the interactions your team members have with others inside and outside Integer.
- You promote a diverse and inclusive work environment where your team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust.
Manufacturing & Design Assurance support:
- You are the first level support for resolving day-to-day issues as they are raised by members of your team and, after assessing the situation, you may seek cross functional and/or organizational support for resolution. To be successful, you will possess the technical understanding and the ability to apply procedures and concepts within your own discipline and basic knowledge of other disciplines.
- You will review and approve engineering change requests, nonconformance reports and engineering reports.
- As part of your responsibilities, you will establish daily/weekly/monthly objectives for your team members and ensure effective communications throughout the team. An element of these objectives includes providing active support for each of your direct reports to aspire to accomplish his/her Individual Development Plans as a roadmap to professional and personal skills development.
- You will drive an appropriate level of process control using a risk-based approach.
- You ensure compliance with the established Quality Management System.
- As an element of our belief that we all Own Quality, you engrain a culture of quality amongst your team.
- As a quality Core Team member, you actively participate in development project teams. Performs quality/reliability engineering activities while providing guidance to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
- You will lead Risk Management (ISO 14971) and Usability program activities. You will lead cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. In addition, you will prepare required deliverables to execute and document the risk management outcomes, controls measures, residual risks in reports. Maintains risk management file for the life of the device.
- You will coordinate and collaborate with R&D in DAE review of technical documentation, develop test methods, and prepare design verification and validation test deliverables. You will plan and conduct compliance testing to recognize international standards.
- As an element of your role, you will coordinate with Advanced Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols.
- You will provide support in supplier and internal auditing (DHF and Technical files for conformance), external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
- You will provide support in conducting root cause analyses, and preparation of CAPA and HHA. Draft and update SOPs
- Other duties as assigned
Provide support of Integer’s Strategic Imperatives:
- You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:
- Strategy Alignment through Site Hoshin Plans, quality planning meetings, and regular updates to QA RA weekly, DA quarterly reviews, and monthly metrics, supporting the walk to 5 sigma and other quality initiatives.
- Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
- Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable and the adoption of Quality Policies and procedures that are aligned to and harmonized with the enterprise (Integer) Quality Management System
- Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
- Systems: Through the adoption and integration of the principles of built in quality and of the Enterprise Quality Procedures.
How you will be measured:
- The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
- Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
- You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
- Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics
- Delivery – Achievement of scheduled tasks and milestones for assigned projects.
- Cost - Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.
- People – You play a key role in promoting Associate engagement. In your role, you will ensure that associate relations’ issues are handled in a timely manner.
What sets you apart:
- Minimum education:
- You have earned, as a minimum, a bachelor’s degree in an engineering or related technical field.
- Minimum experience:
- Specialized knowledge & experience:
- You have knowledge and experience with the specific product line or function you will support, such as manufacturing quality, supplier quality or quality engineering.
- You have specialized knowledge with respect to the quality system regulations and standards important to the performance of this role e.g., EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience
- You will have specialized knowledge in this role's performance e.g., EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience. Practical knowledge of ISO 14971, ISO 62366, IEC 60601-1 and related standards.
- Experience in interpreting electrical design schematics and mechanical design drawings. Preferred experience with FDA Class II, IIb and III mechanical and electro-mechanical medical devices. Skilled in statistical methods e.g., ANOVA, SPC, test sample size g plans, Gauge R&R, and DOE. Demonstrated proficiency utilizing quality lean sigma tools (e.g., Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe). Experience establishing and implementing quality metrics for product development.
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
