Pelham Plastics is dedicated to hiring talented people who bring diverse and new work experience, skills and perspectives. This is the foundation to our team success. We offer an attractive work schedule of 4 day/10 hour work week and opportunity to work on projects, products and processes that result in life saving devices. If we do not have a job posted at this time or in your particular area of interest, we encourage you to apply anytime.
Job Title: Quality Assurance Manager
Department: Quality Assurance
Reports to: Operations Director
Responsible for directing, managing and maintaining the Quality Management System (QMS) in compliance with company policies, customer requirements and applicable ISO standards & certifications. Manages and oversees the quality department, expectations and functions including but not limited to: Quality Control, Document Control and Quality Engineering. Manages and maintains systems to ensure control of raw material and finished goods disposition. Acts as point of contact to address and resolve customer/supplier quality issues. Ensures the Company’s quality objectives are achieved.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
- Directs, manages and maintains the Quality Management Systems (QMS) in compliance with company policies, customer requirements and applicable ISO standards/certification.
- Active member of senior management team, working collaboratively on companywide goals and strategic direction. Responsible for the development, execution, and management of strategic/operational plans for the department, as well as supporting and providing recommendations to the strategic/operational plans for other departments. Stays abreast of the industry compliance/regulatory landscape and offers strategic advice regarding recommendations for internal organizational changes.
- Oversees and coordinates ISO audit activities. Manages, leads and maintains an internal audit program and schedule. Leads internal audits and ensures other internal auditors are appropriately trained and certified.
- Plans for and leads customer and supplier audits.
- Maintains and assesses the company’s Quality Policy and Quality Manual. Reviews for appropriateness and relativity to ISO standard.
- Provides Quality Engineering leadership to support the Manufacturing and Development Engineering departments, and leads Continuous Improvement activities throughout the organization.
- Manages and implements methods and procedures for inspection and process control procedures.
- Responsible for tracking and presenting Quality Metrics (e.g. on-time delivery, customer satisfaction, supplier performance, RTFT, DPM, and non-conformance, CAPA and SCAR trending). Prepares and presents data, results and other quality related information to the senior management team and drives improvements to the Quality Metrics.
- Trains employees and manages training processes as required.
- Manages the Document Control function to ensure systems, databases and procedures comply with the Quality Management System. Participates in the Engineering Change Order (ECO) process, and ensures review, final approval, and release.
- Manages the Quality Control group responsible for the testing and disposition of incoming raw materials, subassemblies, and finished good products.
- Manages the Equipment Calibration program. Ensures equipment is scheduled for calibration and results are well documented.
- Acts as point of contact and responds to quality related customer complaints and issues. Addresses non-conformances, chairs the MRB (Material Review Board) and leads investigations into root cause analysis, containment, identifies/implements the appropriate corrective action/preventative action (CAPA), effectiveness checks and providing follow up communication and problem resolution to customers.
- Manages the Supplier Corrective Action Request (SCAR) program. Communicates with vendors on discrepant product. Conducts root cause analysis and determines containment, appropriate corrective actions and effectiveness of corrective actions. Works with vendors for discrepant product rework or replacement in a timely fashion.
- In conjunction with Engineering, participates in validation process (IQ, OQ, PQ) for new product development process validations and equipment validations. Provides input to statistical analysis, inspection plans and methods, FAI, pFMEA and general validation support.
- Participates in new product development activities to ensure quality considerations are adequately addressed.
- Drives a continuous improvement and lean manufacturing environment with a focus on RTFT and reducing the cost of quality.
- Makes recommendations on the effectiveness of test and measurement equipment and acquires new technology as necessary.
- Responsible for the effective management of employees including policy and procedure interpretation, mentoring, training, growth & development, hiring & termination, teamwork, performance management, pay administration, etc.
- Performs other duties as assigned.
EDUCATION: Bachelor’s degree or the equivalent.
EXPERIENCE: A minimum of 8 years of experience in a manufacturing environment, including 3 years of supervisory/management experience.
SPECIAL SKILLS: Proficiency in quality management systems; Lean Principles; quality engineering practices and principles; in depth knowledge of ISO standards and certification process: ISO 13485:2003; excellent interpersonal, verbal and written communication skills; negotiation skills; proficient in computer applications such as Access, Minitab, Excel, PowerPoint, ERP systems; Six Sigma Black Belt and ASQ Certifications preferred; FDA experience in medical devices required. PHYSICAL REQUIREMENTS: Able to lift up to 20 lbs.; sit, stand, bend and stoop; good visual acuity and capable of fine motor skills.
Job Title: Process Engineer II
Reports to: Engineering Program Manager
Work with the product development team to translate prototypes into production ready, robust manufacturing processes for new products. Lead the development of processes and scale-ups into commercialization. Responsible for identifying and process ranging of critical process inputs and the execution of IQ, OQ and PQ. Support customer and company value through process and design for manufacturability.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
- Perform process development and scale up activities in support of new product development projects using the DMAIC and DFM methodology or equivalent.
- Using 6 Sigma tools, study, define, identify critical process inputs to understand their impact on the
- manufacturing process outputs. Identify and minimize output variation.
- Leads scale-up to test for manufacturing and quality issues
- During development phase, investigate product quality issues through root cause analysis and implementation of corrective actions
- Develop inspection methods and tooling and challenge thru MSA activity
- Execute various project activities in support of a defined Stage Gate process. Presents metrics and objective evidence to upper management to support product maturation through the Stage Gate development life cycle.
- Maintain proper documentation of technical and experimental activities within ISO 13845:2016. Maintain device history records within ISO 13485:2016.
- Development of manufacturing documentation
- Author and execute IQ/OQ/PQ’s and validation plans overseeing the training, builds and testing thru report writing and approval. Lead cross functional team to develop PFMEA’s to identify and mitigate risk. Lead team to develop control plans and understand the impact of validation activities and outcomes on process controls.
- Transitions new and revised processes into manufacturing and performs initial training. Provides continued support for training, as needed, to ensure that operator proficiency is maintained.
- Assesses and tracks yield labor and material to identify variances and defects. Summarizes and compares performance to projected standards and cost models to ensure robust, profitable processes are transferred to MFG
- Maintains compliance to the Pelham Plastics Quality Management System procedures. Adheres to the company’s policies & procedures.
- Performs all other duties as required or assigned
EDUCATION: Bachelor’s degree in Plastics or a related engineering discipline or the equivalent
EXPERIENCE: 4 to 6 years experience in plastics manufacturing and/or the medical devices industry or the equivalent.
SPECIAL SKILLS: Computer literate; word processing, spreadsheets, Solidworks, Minitab
Proficient in design and process FMECA, Process Validation and variability reduction applications; effective organizational, communication and interpersonal skills.
PHYSICAL REQUIREMENTS: Able to lift up to 20 lbs; sit, stand, bend and stoop; good visual acuity and capable of fine motor skills.
Job Title: Assembler (2nd Shift – Part and Full Time)
Reports to: Production Supervisor
We are looking for an Assembler to join our second shift team. We are willing to train the right candidate who meets these requirements:
- Steady work history
- Ability to understand spoken and written instructions in English
- Basic computer skills needed
- Ability to sit or stand for prolonged periods of time
- Enjoy working in a fast-paced team environment
- Good visual capability for inspection, occasionally with magnified ring light
- Manual dexterity to work with small parts in a clean room environment.
Under direct supervision, performs rudimentary assembly operations of a repetitive nature to assemble routine plastic components for the medical device industry.
PRINCIPLE DUTIES AND RESPONSIBILITIES
- Performs rudimentary assembly of plastic medical components in accordance with written and verbal work instructions (WI’s), manufacturing procedures (MP’s) and drawings / blueprints.
- Performs in-process inspection of components for defect awareness.
- Uses fixtures and dies, such as cut to length fixtures, to modify plastic components.
- Performs routine tasks in preparation of assembly such as cutting tubing to specified length and cleaning components.
- Operates routine equipment within the assembly process such as but not limited to, eye coring machine, hot blocks, RF machine, and pad printer to alter parts and tubing configurations.
- Uses measurement devices such as vernier calipers, micrometers and scales in performing routine assembly of plastic components.
- Data entry of component quantities, scrap quantities and defect codes, and other required information into the company’s ERP system with the use of a computer, keyboard, mouse and barcode scanner.
- Adheres to good documentation practices and completes manufacturing documentation as required (i.e., job travelers, run sheets, hourly data, communication board, etc.).
- Maintains work area by making sure work station is in clean and orderly condition and meets the company’s standards for cleanliness, safety and line clearance.
- Maintains compliance to the Company’s Quality Management System procedures and guidelines.
- Notifies the Group Leader or Supervisor when components do not conform to specification.
- Reports any safety related issues to Group Leader or Supervisor.
- Performs other duties as assigned which may include; cleaning, vacuuming and trash disposal.
EDUCATION: High School diploma or equivalent. Ability to read, write and comprehend the English language. Must follow good documentation and manufacturing practices. Ability to follow written and verbal work instructions. Basic computer skills (keyboard and mouse) are required.
EXPERIENCE: 0 – 2 years related experience assembling small parts. Ability to learn to read drawings / blueprints.
SPECIAL SKILLS: Fine motor skills, good mechanical aptitude, ability to learn to use microscope and or magnified ring light. Ability to learn to use measurement devices (Vernier calipers, micrometers, pin gauges, etc.). Ability to work with others in a team environment. Handle and work with sharp objects such as razor blades, cutters and x-acto knives.
PHYSICAL REQUIREMENTS: Ability to push, pull or lift up to 20 lbs; position self to sit, stand, bend and/or stoop for long periods of time without being able to leave the work area; good visual acuity with or without corrective lenses; fine motor skills; and able to work in an environment that requires wearing frocks, shoe covers, hair/beard covers, gloves, hearing protection and safety glasses.
If you are an individual who cares about making quality products that save lives, consider joining our team. You will enjoy great benefits, a supportive team, and a 4-day work week.
Resumes may be submitted via:
- Website: firstname.lastname@example.org
- Mail: Pelham Plastics, Inc., 42 Dick Tracy Drive, PO Box 997, Pelham, NH 03076
- Fax: 603-886-3311