Description for Quality Engineer:
This position is self-directed and is responsible for performing Quality Engineering tasks and activities with limited guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within quality assurance field. Relies on personal experience and judgment to perform primary job responsibilities. This role is primarily an independent contributor with no direct reports. Interaction is potentially with all levels of the organization.
Responsibilities for Quality Engineer:
- Responsible for document management related to assigned projects, such as batch cards, MIs, DHR, DMR, DMF, CAPA, ECO, Validations, IP/PS, customer complaints, FMEA, Customer Proposals, Drawings, Design Control, SDS’, Calibrations, PM, NCR, Product Shipping, and Label Control.
- Participates in customer and regulatory audits as well as internal audits. When trained may be lead internal or external auditor. Some travel may be required.
- Responsible for the 21 CFR 820, ISO 13485, and cGMP compliance of the assigned PMI programs.
- Participates in project meetings (product design or internal improvements) as Quality representative supporting compliance and PMI Quality position.
- Meets annual Quality Objectives as set with Quality Manager as well as assigned Quality metrics.
- Recommends and implements Quality process improvements with the approval of Quality Manager.
- Participate in validation teams or work on equipment validations, as requested.
- Supports compliance to Good Documentation Practices in document review and approval.
- Utilize technical capacity and knowledge of 21 CFR 820 and ISO 13845 standards to understand the scope of the problem and provide recommendations to support and defend the Quality Management Systems in projects with sound decisions and consistent feedback.
- Demonstrate leadership skills and communication proficiency to mentor peers in Quality areas, including data analysis, sampling rationale, document reviews, risk-based decision making, and conflict resolution for Quality-related issues.
- Multitask, prioritize, and meet deadlines in timely manner without excessive follow-up.
- Exhibit strong organizational and verbal/written communication skills at multiple levels in the organization.
- Perform additional duties as assigned.
Required Knowledge, Skills and Abilities for Quality Engineer:
- 2+ years hands on experience in a quality role in a regulated industry such as medical device or pharmaceutical
- Skilled with Microsoft Office Software (Microsoft Word, Excel, et. al.)
- Good knowledge of statistics and Mini-tab software
- Good work organizational skills
- Ability to manage time and prioritize
- Excellent communication and interpersonal skills
- Ability to collaboratively interact with people at all levels of the organization
- Good technical writing skills, grammar
- Ability to handle highly confidential business information
- Strong attention to detail
- Ability to think proactively, troubleshoot, investigate and improve systems
- Highly responsible for actions of self and possibly others on the team
Education/Experience Requirements
- Required- Bachelor’s Degree (preferably in Engineering discipline) and 2+ years of Medical Device or Pharmaceutical quality experience
Preferred Qualifications
- Experience with equipment, process, software, or automation validation and statistical analysis, generating sample plans, scaling up processes, process mapping
Working Conditions at Poly-Med, Inc.
At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.
Physical Requirements:
Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.
Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.
Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
Job Type: Full-time
Pay: $65,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Application Question(s):
- Will you now or in the future require employer sponsorship for employment visa status (e.g., H-1B)?
Education:
Experience:
- ISO 13485: 1 year (Required)
- validation: 1 year (Preferred)
- CAPA: 1 year (Required)
- FDA regulations: 1 year (Required)
Work Location: In person
