Putnam Plastics Corporation (PPC) is the industry leading manufacture of life-saving medical devices components for over 40 years. We are looking for people who want to invest in their future, the future of PPC and our PPC community. Please refer to our website at putnamplastics.com/about/career-opportunities for more information. This is a summary only. We are an EEO employer. Summary: The Lead Quality Engineer has oversight, offers support and mentorship of a Quality Engineering group consisting of Quality Engineers and Quality Control Technicians. This role also has direct Quality Engineering responsibilities; using quality and process engineering principles, tools and practices to investigate, analyze, develop and optimize processes for ensuring continued compliance and product quality. The Lead Quality Engineer actively participates in continuous improvement initiatives as assigned and offers and supports ideas for improvement. Essential Duties & Responsivities: - Assists in data gathering, reporting or evaluation regarding key performance indicators.
- Support and mentor team members on investigation, critical thinking, data analysis, root cause analysis or other direct quality engineering activities, bringing actions to a close.
- Supports team members to bring their individual assignments to closure.
- Serves as a liaison and advocates for the quality engineering group to internal and external customers.
- Provides hands-on examples of the proper use of metrology equipment, measurement methods and sample preparation.
- Is conscientious of daily changing situations and the need to determine priority shifts.
- Coordinates quality engineering activities with appropriate team members, as well as interdepartmental teams.
- Acts as a professional representation of the quality engineering group.
- Manages projects, schedules and priorities, as appropriate.
- Consistently driving for resolution and team efficiency.
- Resolves conflicts independently and professionally.
- Assists in other quality or engineering activities as requested
Sustaining Engineering & New Product Initiation: - Acts as an advocate to ensure processes are compliant and documented.
- Reviews, evaluates product specifications and applies appropriate measurement methods to critical-to-quality (CTQ) attributes.
- Is hands-on with products, inspection and measurement equipment.
- Drive change control processes and activities.
- Participates in CAPA activities as required.
- Initiates CCOs and revises or creates documentation when needed.
- Authors protocols and reports, develops and takes action related to validation activities such as, but not limited to Risk Management, MSA, FAI, IQ, OQ, PQ, PPAP, Gage R&R, Process Capability (statistical process control), DOE, or other studies necessary to initiate or sustain products.
- Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements.
- Assists in other quality or engineering activities as requested.
- Evaluates process critical quality parameters and updates specifications and protocols.
- Customer Feedback and Nonconformance Support:
- Documents and Investigates customer feedback and/or nonconformances.
- Participate and collaborate with Supply chain, R&D Engineering and Manufacturing Engineering to identify potential areas of process variability, address root causes and implement improvements.
- Tracks and reports performance metrics pertaining to Customer Feedback and nonconformances to identify trends.
- Corresponds professionally with internal and external customers regarding potential product issues.
Required Qualifications: Bachelor’s degree in Engineering or Science, or equivalent work experience. - A minimum of five (5) years related to manufacturing experience in a QMS environment.
- A minimum for one (1) year related to direct supervisory experience of 3 or more.
- Working knowledge of ISO 9001, ISO 13485 or other regulated manufacturing industries.
- Highly proficient in the use of Microsoft Office including Outlook, Word, Excel, Power Point, Project, Visio, SharePoint, Teams, and Adobe Acrobat Pro.
- Previous familiarity with Minitab or other Statistical Programs.
- Excellent analytical, technical and interpersonal skills.
- Demonstrated meticulous attention to detail and accuracy.
- Experience working both individually and as part of a team to meet both internal and external customer requirements
- Able to perform several tasks concurrently with good time management skills.
Preferred Qualifications: - Experience working with plastics.
- ASQ CQE/CQA
- Lean Six Sigma (Green Belt or Black Belt). Prior experience within electronic Quality Management Systems (eQMS) such as CEBOS, Green Light Guru, Master Control, Qualio, Veeva, or similar applications and systems.
- Oversight of teams with more than 5 people and within multiple locations.
Physical Requirements: (with or without the aid of mechanical) The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Regularly required to stand, sit, walk, use hands to input, handle or feel, use of arms to reach, able to hear and talk. - Must possess fine hand motor skills to handle small manufacturing tools, QC tools and fine product.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Must be able to use hand tools include but not limited to scissors, pliers, razor blades, wire snips.
- Required to stand/walk for majority of an 8-hour work shift and lift/push/pull up to 25lbs occasionally throughout work shift.
- Works in an office environment and on manufacturing floor.
- Periodically, overtime may be required, including weekends.
- Cross training.
- Some travel, including between PPC owned properties, customer or supplier sites is required.
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