Government, Regulatory and Code, Healthcare, Quality Engineering
4 Year Degree
Quality oversees the development of quality systems, standards and protocols for quality assurance testing models. Quality assists in the design and implementation of policies and procedures for quality systems, product and process controls, testing and evaluating the precision and accuracy of products and/or equipment. The Quality Manager will be expected to provide leadership and management for QA activity in a manufacturing facility; interact with customers and provide leadership support for Engineering, Quality Systems and Process engineering.
The Quality Assurance Manager will manage three to four Quality Engineers, eleven hourly inspectors working over three shifts, and one document control person. Everyone at Perryman Company Forge works in quality. Production has made significant process time reductions and so quality must now strive to reduce in process and final inspection times through rational reductions in sampling and improved inspection equipment or techniques.
Key Result Accountabilities
Serves as management representative.
Work collaboratively with Engineering, Operations, and other functional groups to successfully and seamlessly deliver to customers an integrated set of services and products.
Work collaboratively with site management team to successfully and seamlessly deliver to customers an integrated set of services and products.
Ensures output, timeliness, quality and cost to standards consistent with customer requirements and company strategy.
Support strategies to help drive improvements in operational capability required to support corporate growth and strategies.
Reduce manufacturing operations costs through innovation, productivity gains, and enhanced inspection techniques and technologies.
Be a resource and mentor to other members of the management team, with a responsibility to develop people and support corporate goals of employee engagement.
Talent acquisition and development. Recommends and executes personnel actions including promotions, performance reviews and any disciplinary measures.
Responsible for business improvement programs and initiatives such as Complaint reduction, Quality System improvements (CAPA, NCR, Training, etc), cost improvement programs through Lean Manufacturing techniques and drive successful business excellence programs for manufacturing to support business opportunities.
Create a continuous improvement culture that strives to satisfy customer requirements for fill-rates and zero defects.
Complies with all work rules including those pertaining to safety, health, quality and Perryman Quality Management System.
Develop and drive implementation of the quality system architecture, staffing, and associated processes to ensure adequate checks and balances exist as well as establishing the appropriate independence of the quality function.
Leads bi-weekly management reviews, to ensure the quality system is suitable and effective to satisfy regulatory requirements and the company's quality policy and objectives and other applicable procedures and practices at all levels of the organization.
Develops and drives a work culture fostering a highly ethical environment grounded in credibility and trust and fully committed to patient safety, compliance, quality and customer focus.
Builds a strong quality team through staffing, leadership and training serving as a role model that drives improved compliance practices.
Performs other duties as necessary.
Typically Bachelors degree in engineering, equivalent degree or extensive work experience
5 - 10 years experience in manufacturing, preferably medical devices, pharmaceuticals, aerospace, food, automotive or other regulated industries, including at least three years leadership responsibilities with increasing responsibility in quality assurance or associated fields.
Must be familiar with and understand recognized regulations and standards such as (where applicable)
US – 21 CFR Part 820 (FDA QSR, cGMP)
ISO 13485 - (EN) ISO 13485 Medical Devices – Quality Management Systems
EU - Medical Device Directive (MDD) 93/42/EEC
ISO 14971 Risk Management
ISO 9001 Quality Management Systems
Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerencing and mechanical drawings and associated software packages. Experience with FDA, IQ, OQ, and PQ protocols and other medical device validation methods is very important.
Familiar with Six Sigma and/or a history of lean manufacturing, Kaizen and 5S, etc. Six-Sigma certified or willing to obtain certification preferred.
Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills.
Knowledge of machining, metals and plastics processing and fabrication, and product assembly in the medical device industry.
Working knowledge of capacity planning and logistics management.
Demonstrated leadership and team building skills.
Ability to interface with customers, problem solve and drive solutions to meet customer requirements.
Hands on leader with demonstrated experience at successful high performance team building as a coach and mentor.
Strong communicator with internal and external customers in all areas of the business: written and verbal (one-on-one and group).
Strategic thinker: responsible for developing the plan; ability to conceptualize coherent view of facility in the future (6 months, one year, two years, five years).
Rational thinker: good business judgment and ethics.
Demonstrated ability to lead organizations and blend together diverse skill sets. Dedicated to results through the achievement of their people and organization.
Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change. Self-motivated with a sense of urgency and accountability. Energetic and hardworking.
High level of intellectual curiosity combined with strong problem solving and analytical skills. Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions.
It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
About Perryman Company
Located in Houston, PA, Perryman Forge & Fabrication is a certified ISO 13485:2003, ISO 9001:2008, and AS9100 Rev C facility offering medical device contract manufacturing. We specialize in machining titanium, stainless steel, aluminum, cobalt chrome, and medical grade plastics for implants, trials, and instruments.
Our forging operation offers high quality, low- to mid- volume products in an array of titanium, cobalt chrome, and stainless steel shapes. Perryman Forge & Fabrication specializes in adding value through machining, finishing, and managing outside processing vendors to provide a finished product for our customers. We also forge intermediate items for our customers to process further at their facility.
We offer the highest quality at a competitive price by implementing lean principals, such as SMED, KANBAN, and 5S, throughout the entire organization.