Senior Quality Manager

About Parks

First established in 1961, Parks Medical Electronics has a long, established history as the industry’s most experienced manufacturer of Doppler ultrasound systems. Founded as Parks Electronics Laboratory by Loren Parks to manufacture plethysmographs of his own design, the Parks product line grew to include impedance plethysmographs, mercury strain gauge plethysmographs, hearing testers, EKG telephone telemetry, and exercise EKG telemetry in the years before Doppler.

Parks products are still manufactured domestically at our Oregon facility, allowing us to support products we produce for years beyond the norm. Many of the products we sold over 30 years ago are still in use today… and are still supported by Parks. In a business that has seen numerous competitors come and go, leaving customers without support, Parks has been a constant throughout and remains the industry leader today.

Reports to:

COO/President

Summary:

Provides quality control and assurance functions that ensure products conform to engineering specifications and meet customer quality requirements by performing the following duties.

• Manages the company QMS (Quality Management System) and quality documentation processes
• Owns all facets of regulatory reporting, including FDA, ISO, and customer‑specific audit requirements.
• Monitors and interprets regulatory changes and assesses impact to products and processes
• Owns and maintains controlled documentation including SOPs, work instructions, and records
• Leads internal audits and supports external audits (FDA, ISO, Notified Body, customers)
• Manages CAPA, nonconformances, complaints, and change control processes
• Oversees management review and quality metrics reporting
• Reports/tracks any significant deviations from quality standards and recommends corrective actions as necessary to management
• Ensures supplier qualification, audits, and ongoing monitoring
• Supports manufacturing transfer, process validation, and production controls
• Reviews and approves DHRs, DHFs, and technical files
• Participates in new product development to ensure proper quality assurance and control plans can be implemented
• Oversees complaint handling, vigilance reporting, and adverse event submissions (MDRs, vigilance reports)
• Supports post‑market surveillance planning and execution
• Coordinates field actions, recalls, and corrective actions as needed
• Oversees the manufacturing process related to quality control and production
• Maintains problem‑solving and troubleshooting skills for manufacturing concerns/issues
• Manages customer complaints related to production and quality control
• Participates as an active member in ISO, GMP, safety, process development, and executive management teams
• Provides support in improving efficiencies related to Quality Control and production departments.
• Performs other duties as assigned

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's degree (B.A. or B.S.) from a four‑year college or university; and six to eight years related experience and/or training; or an equivalent combination of education and experience.

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Knowledge of ISO 13485, Food and Drug Administration Part 820
• Knowledge of EU medical device directives and other applicable country directives
• Organizational and leadership…